Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine
Sponsor
ViiV Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT03078556
Collaborator
GlaxoSmithKline (Industry)
154
1
6
4.7
32.6
Study Details
Study Description
Brief Summary
This study aims to compare the bioequivalence of two experimental fixed dose combination (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in healthy adult subjects. The study will be carried out in two parts. Part 1 of the study will be open label, up to 3 periods design with a wash out period of at least 7 days between treatment periods. Subjects will be randomized to receive either single entities or formulation 1 FDC of DTG and 3TC in a crossover manner in first 2 periods. The first 16 subjects who complete the first two treatment periods and consent to continue will receive a single dose of FDC formulation 1 tablet administered with a high fat meal for a third treatment period. In Part 2 of the study, subjects will be randomized to receive either single entities or formulation 2 FDC of DTG and 3TC in a crossover manner in first 2 periods. Similarly the first 16 subjects will then receive FDC formulation 2 tablets with high fat meal in treatment period 3. Subjects will have a follow-up visit within 7-14 days after the last dose of study drug. Approximately 76 healthy subjects will be included in Part 1 of the study and if Part 2 of the study is conducted, another 76 healthy subjects will be included. The total duration will be approximately 11 weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
154 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Randomized, Single Dose, Crossover, Pivotal Bioequivalence Study of Fixed-dose Combination Tablets of Dolutegravir and Lamivudine Versus Dolutegravir and Lamivudine Single Entities and Food Effect Assessment in Healthy Volunteers
Actual Study Start Date
:
Mar 27, 2017
Actual Primary Completion Date
:
Aug 18, 2017
Actual Study Completion Date
:
Aug 18, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment sequence A/B: Part 1 Eligible subjects will be randomized in sequence A/B and will receive A: DTG 50 milligram (mg) and 3TC 300 mg single entities in Period 1, B: DTG 3TC FDC formulation 1 tablet in Period 2. |
Drug: Dolutegravir
Single dose of DTG 50 mg tablet along with 3TC (EPIVIR) tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water. DTG will be a white, film coated, round tablet engraved with SV 572 on one side and 50 on the other side.
Drug: Lamivudine
Single dose 3TC (commercial name: EPIVIR) 300 mg tablet along with DTG tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water.<br>3TC will be gray, diamond shaped tablet, engraved "GX EJ7" on one side and plain on the other side.
Drug: Dolutegravir + Lamivudine FDC Formulation 1
Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 1 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) of Part 1 and the first 16 subjects in treatment period 3 (under fed) of Part 1 with 240 mL of room temperature water. <br>FDC formulation 1 tablets will be oval, biconvex, white, film coated tablet engraved 'SV H7I' on one face.
|
| Experimental: Treatment sequence B/A: Part 1 Eligible subjects will be randomized in sequence B/A and will receive B: DTG 3TC FDC formulation 1 tablet in Period 1 and A: DTG 50 mg and 3TC 300 mg single entities in Period 2. |
Drug: Dolutegravir
Single dose of DTG 50 mg tablet along with 3TC (EPIVIR) tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water. DTG will be a white, film coated, round tablet engraved with SV 572 on one side and 50 on the other side.
Drug: Lamivudine
Single dose 3TC (commercial name: EPIVIR) 300 mg tablet along with DTG tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water.<br>3TC will be gray, diamond shaped tablet, engraved "GX EJ7" on one side and plain on the other side.
Drug: Dolutegravir + Lamivudine FDC Formulation 1
Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 1 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) of Part 1 and the first 16 subjects in treatment period 3 (under fed) of Part 1 with 240 mL of room temperature water. <br>FDC formulation 1 tablets will be oval, biconvex, white, film coated tablet engraved 'SV H7I' on one face.
|
| Experimental: Subjects receiving high fat meal: Part 1 Eligible subjects will be administered single dose of DTG 3TC FDC formulation 1 tablet with high fat meal in Period 3 to study the effect of food on tablet. |
Drug: Dolutegravir + Lamivudine FDC Formulation 1
Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 1 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) of Part 1 and the first 16 subjects in treatment period 3 (under fed) of Part 1 with 240 mL of room temperature water. <br>FDC formulation 1 tablets will be oval, biconvex, white, film coated tablet engraved 'SV H7I' on one face.
|
| Experimental: Treatment sequence A/C: Part 2 Eligible subjects will be randomized in sequence A/B and will receive A: DTG 50 mg and 3TC 300 mg single entities in Period 1 and C: DTG 3TC FDC formulation 2 tablet in Period 2. |
Drug: Dolutegravir
Single dose of DTG 50 mg tablet along with 3TC (EPIVIR) tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water. DTG will be a white, film coated, round tablet engraved with SV 572 on one side and 50 on the other side.
Drug: Lamivudine
Single dose 3TC (commercial name: EPIVIR) 300 mg tablet along with DTG tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water.<br>3TC will be gray, diamond shaped tablet, engraved "GX EJ7" on one side and plain on the other side.
Drug: Dolutegravir + Lamivudine FDC Formulation 2
Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 2 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) and the first 16 subjects in treatment period 3 (under fed) of Part 2 with 240 mL of room temperature water. <br>FDC formulation 2 tablets will be oval, biconvex, white, film coated tablet engraved 'SV 13N' on one face.
|
| Experimental: Treatment sequence C/A: Part 2 Eligible subjects will be randomized in sequence C/A and will receive C: DTG 3TC FDC formulation 2 tablet in Period 1 and A: DTG 50 milligram (mg) and 3TC 300 mg single entities in Period 2. |
Drug: Dolutegravir
Single dose of DTG 50 mg tablet along with 3TC (EPIVIR) tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water. DTG will be a white, film coated, round tablet engraved with SV 572 on one side and 50 on the other side.
Drug: Lamivudine
Single dose 3TC (commercial name: EPIVIR) 300 mg tablet along with DTG tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water.<br>3TC will be gray, diamond shaped tablet, engraved "GX EJ7" on one side and plain on the other side.
Drug: Dolutegravir + Lamivudine FDC Formulation 2
Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 2 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) and the first 16 subjects in treatment period 3 (under fed) of Part 2 with 240 mL of room temperature water. <br>FDC formulation 2 tablets will be oval, biconvex, white, film coated tablet engraved 'SV 13N' on one face.
|
| Experimental: Subjects receiving high fat meal: Part 2 Eligible subjects will be administered single dose of DTG 3TC FDC formulation 2 tablet with high fat meal in Period 3 to study the effect of food on tablet. |
Drug: Dolutegravir + Lamivudine FDC Formulation 2
Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 2 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) and the first 16 subjects in treatment period 3 (under fed) of Part 2 with 240 mL of room temperature water. <br>FDC formulation 2 tablets will be oval, biconvex, white, film coated tablet engraved 'SV 13N' on one face.
|
Outcome Measures
Primary Outcome Measures
- Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the pharmacokinetic (PK) profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
- AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at given time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted conditions in Periods 1 and 2 of Part 2.
- Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
- AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
- Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
- Cmax of Plasma DTG and 3TC in the Fasted State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
Secondary Outcome Measures
- Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
- Tlag of DTG and 3TC in Fasted State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
- Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
- Tmax of DTG and 3TC in the Fasted State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
- Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
- Tlast of DTG and 3TC in the Fasted State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
- Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
- t1/2 of DTG and 3TC in the Fasted State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2
- Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
- Lambda z of DTG and 3TC in in the Fasted State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
- Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
- Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
- AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
- AUC(0-24) of DTG and 3TC in the Fasted State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
- Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
- CL/F of DTG and 3TC in the Fasted State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
- Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
- Vz/F of DTG and 3TC in the Fasted State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
- Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
- C24 of DTG and 3TC in the Fasted State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
- Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1.
- Clast of DTG and 3TC in the Fasted State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2.
- AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
- AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
- AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
- AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
- Cmax of Plasma DTG and 3TC in the Fed State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
- Cmax of Plasma DTG and 3TC in the Fed State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
- Tlag of DTG and 3TC in Fed State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
- Tlag of DTG and 3TC in Fed State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
- Tmax of DTG and 3TC in the Fed State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
- Tmax of DTG and 3TC in the Fed State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
- T1/2 of DTG and 3TC in the Fed State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
- T1/2 of DTG and 3TC in the Fed State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
- Lambda z of DTG and 3TC in in the Fed State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
- Lambda z of DTG and 3TC in in the Fed State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
- Clast of DTG and 3TC in in the Fed State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
- Clast of DTG and 3TC in in the Fed State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
- Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
- Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
- AUC(0-24) of DTG and 3TC in the Fed State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
- AUC(0-24) of DTG and 3TC in the Fed State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
- CL/F of DTG and 3TC in the Fed State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
- CL/F of DTG and 3TC in the Fed State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
- Tlast of DTG and 3TC in the Fed State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
- Tlast of DTG and 3TC in the Fed State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
- Vz/F of DTG and 3TC in the Fed State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
- Vz/F of DTG and 3TC in the Fed State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
- C24 of DTG and 3TC in the Fed State: Part 1 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1.
- C24 of DTG and 3TC in the Fed State: Part 2 [Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose]
Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2.
- Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 [Up to Day 31 in Part 1 and Part 2]
SBP and DBP were measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for SBP and DBP for Part 1 and 2 is presented.
- Change From Baseline in Heart Rate (HR): Part 1 and 2 [Up to Day 31 in Part 1 and Part 2]
HR was measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for HR for Part 1 and 2 is presented.
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2 [Up to Week 11]
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Participants having any AE or SAE are presented.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
-
Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac evaluation (history, electrocardiogram [ECG]).
-
A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
-
Subject must be able to swallow 2 tablets at the same time (Reference tablets only).
-
Body weight >=50 kilogram (kg) for men and >=45 kg for women and body mass index (BMI) within the range 18.5-31.0 kg per meter square (kg/m^2).
-
Male or Female. Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative serum or urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: 1. non-reproductive potential defined as: pre-menopausal females with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; documented bilateral Oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea; in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. 2. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and until at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer after the last dose of study medication and completion of the follow-up visit.
-
Capable of giving signed informed consent which includes compliance with the requirements and restrictions.
Exclusion Criteria:
-
Alanine aminotransferase (ALT) and bilirubin >1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percentage).
-
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
-
QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 450 milliseconds (msec).
-
Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and ViiV Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
-
History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces [360 milliliter (mL)] of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
-
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 1 month prior to screening.
-
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
-
Creatinine clearance (CrCL) <90 mL/minute.
-
A positive hepatitis B surface antigen (HBsAg) or a positive hepatitis B core antibody with a negative hepatitis B surface antibody, positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
-
A positive pre-study drug/alcohol screen.
-
A positive test for HIV antibody.
-
Where participation in the study would result in donation of blood or blood product in excess of 500 mL within 56 days.
-
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
-
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Overland Park | Kansas | United States | 66211 |
Sponsors and Collaborators
- ViiV Healthcare
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, ViiV Healthcare
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT03078556
Other Study ID Numbers:
- 204994
First Posted:
Mar 13, 2017
Last Update Posted:
Feb 21, 2019
Last Verified:
Aug 1, 2018
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ViiV Healthcare
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study was conducted in 2 parts (Part 1 and Part 2) at a single center in the United States from 27-March-2017 to 18-August-2017 and 154 participants (78 in Part 1 and 76 in Part 2) were randomized. First 16 participants completing the first 2 dosing periods, returned for a 3rd treatment period and received single dose of FDC with high fat meal |
|---|---|
| Pre-assignment Detail | A total of 283 (Part 1: 150, Part 2: 133) participants were screened for this study; 125 (Part 1: 72, Part2: 53) participants were screen failures (SF) and 4 participants were reserved but not used. The reasons for SF: inclusion/exclusion criteria not met (105), withdrew consent (18), physician decision (2). |
| Arm/Group Title | Part 1:DTG+EPIVIR/DTG+3TC Monolayer/DTG+3TC Monolayer-fed | Part 1:DTG+3TC Monolayer/DTG+EPIVIR/DTG+3TC Monolayer-fed | Part 2:DTG+EPIVIR/DTG+3TC Bilayer/DTG+3TC Bilayer-fed | Part 2:DTG+3TC Bilayer/DTG+EPIVIR /DTG+3TC Bilayer-fed |
|---|---|---|---|---|
| Arm/Group Description | Participants were randomized to receive dolutegravir (DTG) 50 milligram (mg) tablet plus a single lamivudine (3TC) tablet in Period 1 followed by DTG 50 mg/3TC 300 mg fixed dose combination (FDC) monolayer formulation in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods. | Participants were randomized to receive DTG 50 mg/3TC 300 mg FDC monolayer formulation in Period 1 followed by DTG 50 mg tablet plus a single 3TC tablet in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods. | Participants were randomized to receive DTG 50 mg tablet plus a single 3TC tablet in Period 1 followed by DTG 50 mg/3TC 300 mg FDC bilayer formulation in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods. | Participants were randomized to receive DTG 50 mg/3TC 300 mg FDC bilayer formulation in Period 1 followed by DTG 50 mg tablet plus a single 3TC tablet in Period 2. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout of 7 days between treatment periods. |
| Period Title: Treatment Period 1 (4 Days) | ||||
| STARTED | 39 | 39 | 38 | 38 |
| COMPLETED | 39 | 38 | 38 | 38 |
| NOT COMPLETED | 0 | 1 | 0 | 0 |
| Period Title: Treatment Period 1 (4 Days) | ||||
| STARTED | 39 | 38 | 38 | 38 |
| COMPLETED | 37 | 36 | 37 | 37 |
| NOT COMPLETED | 2 | 2 | 1 | 1 |
| Period Title: Treatment Period 1 (4 Days) | ||||
| STARTED | 37 | 36 | 37 | 37 |
| COMPLETED | 37 | 36 | 37 | 37 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
| Period Title: Treatment Period 1 (4 Days) | ||||
| STARTED | 9 | 7 | 7 | 9 |
| COMPLETED | 9 | 7 | 7 | 9 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
| Period Title: Treatment Period 1 (4 Days) | ||||
| STARTED | 9 | 7 | 7 | 9 |
| COMPLETED | 9 | 7 | 7 | 9 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Part 1 | Part 2 | Total |
|---|---|---|---|
| Arm/Group Description | Participants were randomized into treatment sequence A/B (treatment A in Period 1 followed by B in Period 2) or B/A (treatment B in Period 1 followed by A in Period 2), where A=dolutegravir (DTG) 50 milligram (mg) tablet plus a single lamivudine (3TC) tablet and treatment B= DTG 50 mg/3TC 300 mg fixed dose combination (FDC) monolayer formulation. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC monolayer tablet formulation administered with a high fat meal in Period 3. There was a washout period of at least 7 days between each treatment period. In treatment periods 1 and 2, single dose of the treatments were administered in the fasted state. | Participants were randomized into treatment sequence A/C (treatment A in Period 1 followed by C in Period 2) or C/A (treatment C in Period 1 followed by A in Period 2), where A=DTG 50 mg tablet plus a single 3TC tablet and treatment C= DTG 50 mg/3TC 300 mg FDC bilayer formulation. The first 16 participants who completed treatment periods 1 and 2, received a single dose of the FDC bilayer tablet formulation administered with a high fat meal in Period 3. There was a washout period of at least 7 days between each treatment period. | Total of all reporting groups |
| Overall Participants | 78 | 76 | 154 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
29.4
(9.37)
|
31.6
(11.18)
|
30.5
(10.33)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
25
32.1%
|
26
34.2%
|
51
33.1%
|
| Male |
53
67.9%
|
50
65.8%
|
103
66.9%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| American Indian or Alaska Native |
6
7.7%
|
1
1.3%
|
7
4.5%
|
| Asian- Central/South Asian Heritage |
1
1.3%
|
1
1.3%
|
2
1.3%
|
| Asian- East Asian Heritage |
0
0%
|
1
1.3%
|
1
0.6%
|
| Asian- South East Asian Heritage |
1
1.3%
|
0
0%
|
1
0.6%
|
| Black or African American |
20
25.6%
|
23
30.3%
|
43
27.9%
|
| White-White/Caucasian/European Heritage |
50
64.1%
|
50
65.8%
|
100
64.9%
|
Outcome Measures
| Title | Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity [AUC (0-Inf)] of Plasma DTG and 3TC in the Fasted State: Part 1 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the pharmacokinetic (PK) profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter Bioequivalence (BE) Summary Population comprised of all participants who have evaluable PK parameters for both analytes and for both Period 1 and Period 2. |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 73 | 73 |
| DTG |
43.1456
(39.29)
|
54.8793
(31.60)
|
| 3TC |
12.3337
(19.88)
|
12.7603
(19.77)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.2710 | |
| Confidence Interval |
(2-Sided) 90% 1.1894 to 1.3582 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.0341 | |
| Confidence Interval |
(2-Sided) 90% 1.0097 to 1.0591 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma 3TC has been presented. | |
| Title | AUC (0-Inf) of Plasma DTG and 3TC in the Fasted State: Part 2 |
|---|---|
| Description | Blood samples were collected at given time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted conditions in Periods 1 and 2 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed, represented by n= X,X in the category titles. |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | C: DTG 50 mg/ 3TC 300 mg Bilayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 74 | 74 |
| DTG, n= 74,74 |
47.2391
(40.29)
|
54.5594
(32.12)
|
| 3TC, n= 73,74 |
12.7713
(18.63)
|
13.5624
(17.94)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.1550 | |
| Confidence Interval |
(2-Sided) 90% 1.0699 to 1.2468 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (C/A) of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.0635 | |
| Confidence Interval |
(2-Sided) 90% 1.0413 to 1.0861 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (C/A) of plasma 3TC has been presented. | |
| Title | Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Time Point (AUC[0-t]) of Plasma DTG and 3TC in the Fasted State: Part 1 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population. |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 73 | 73 |
| DTG |
41.4207
(39.36)
|
52.8754
(31.16)
|
| 3TC |
12.1571
(20.19)
|
12.6147
(19.75)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.2756 | |
| Confidence Interval |
(2-Sided) 90% 1.1919 to 1.3651 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.0372 | |
| Confidence Interval |
(2-Sided) 90% 1.0116 to 1.0634 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma 3TC has been presented. | |
| Title | AUC(0-t) of Plasma DTG and 3TC in the Fasted State: Part 2 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | C: DTG 50 mg/ 3TC 300 mg Bilayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 74 | 74 |
| DTG |
45.2043
(39.57)
|
52.3372
(31.46)
|
| 3TC |
12.4790
(19.19)
|
13.3552
(18.10)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.1578 | |
| Confidence Interval |
(2-Sided) 90% 1.0718 to 1.2507 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (C/A) of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.0702 | |
| Confidence Interval |
(2-Sided) 90% 1.0464 to 1.0946 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (C/A) of plasma 3TC has been presented. | |
| Title | Maximum Observed Concentration (Cmax) of Plasma DTG and 3TC in the Fasted State: Part 1 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 73 | 73 |
| DTG |
2.4065
(38.95)
|
3.0817
(31.86)
|
| 3TC |
2.6650
(29.04)
|
3.1885
(28.07)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.2805 | |
| Confidence Interval |
(2-Sided) 90% 1.1890 to 1.3790 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.1956 | |
| Confidence Interval |
(2-Sided) 90% 1.1437 to 1.2498 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma 3TC has been presented. | |
| Title | Cmax of Plasma DTG and 3TC in the Fasted State: Part 2 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | B: DTG 50 mg/ 3TC 300 mg Bilayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50mg and 3TC 300mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 74 | 74 |
| DTG |
2.5531
(36.38)
|
2.9132
(30.55)
|
| 3TC |
2.4428
(28.25)
|
3.2185
(29.30)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.1410 | |
| Confidence Interval |
(2-Sided) 90% 1.0533 to 1.2361 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (C/A) of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.3176 | |
| Confidence Interval |
(2-Sided) 90% 1.2616 to 1.3760 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (C/A) of plasma 3TC has been presented. | |
| Title | Absorption Lag Time (Tlag) of DTG and 3TC in Fasted State: Part 1 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 73 | 73 |
| DTG |
0.0000
|
0.0000
|
| 3TC |
0.0000
|
0.0000
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 0.000 | |
| Confidence Interval |
(2-Sided) 90% 0.000 to 0.000 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 0.000 | |
| Confidence Interval |
(2-Sided) 90% 0.000 to 0.000 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma 3TC has been presented. | |
| Title | Tlag of DTG and 3TC in Fasted State: Part 2 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | C: DTG 50 mg/ 3TC 300 mg Bilayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 74 | 74 |
| DTG |
0.0000
|
0.0000
|
| 3TC |
0.0000
|
0.0000
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 0.000 | |
| Confidence Interval |
(2-Sided) 90% -0.004 to 0.000 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 0.000 | |
| Confidence Interval |
(2-Sided) 90% 0.000 to 0.000 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma 3TC has been presented. | |
| Title | Time to Reach Maximum Plasma Concentration (Tmax) of DTG and 3TC in the Fasted State: Part 1 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population. |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 73 | 73 |
| DTG |
2.0072
|
2.0017
|
| 3TC |
1.0047
|
1.0008
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | -0.127 | |
| Confidence Interval |
(2-Sided) 90% -0.500 to 0.248 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | -0.126 | |
| Confidence Interval |
(2-Sided) 90% -0.253 to -0.001 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma 3TC has been presented. | |
| Title | Tmax of DTG and 3TC in the Fasted State: Part 2 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2 |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | C: DTG 50 mg/ 3TC 300 mg Bilayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 74 | 74 |
| DTG |
2.5008
|
2.5004
|
| 3TC |
1.0063
|
1.0011
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | -0.127 | |
| Confidence Interval |
(2-Sided) 90% -0.497 to 0.132 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | -0.248 | |
| Confidence Interval |
(2-Sided) 90% -0.376 to -0.001 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma 3TC has been presented. | |
| Title | Time of the Last Quantifiable Concentration (Tlast) of DTG and 3TC in the Fasted State: Part 1 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 73 | 73 |
| DTG |
72.0031
|
71.9303
|
| 3TC |
71.9289
|
71.9303
|
| Title | Tlast of DTG and 3TC in the Fasted State: Part 2 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2 |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | C: DTG 50 mg/ 3TC 300 mg Bilayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 74 | 74 |
| DTG |
71.6813
|
71.8243
|
| 3TC |
71.7138
|
71.8153
|
| Title | Time to Reach Half the Maximum Plasma Concentration (t1/2) of DTG and 3TC in the Fasted State: Part 1 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 73 | 73 |
| DTG |
14.6917
|
14.7557
|
| 3TC |
17.0395
|
17.3436
|
| Title | t1/2 of DTG and 3TC in the Fasted State: Part 2 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2 |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed indicated by n=X in category titles. |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | C: DTG 50 mg/ 3TC 300 mg Bilayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 74 | 74 |
| DTG, n= 74,74 |
15.1538
|
14.7893
|
| 3TC, n= 73,74 |
17.8421
|
18.1071
|
| Title | Apparent Elimination Rate Constant (Lambda z) of DTG and 3TC in the Fasted State: Part 1 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 73 | 73 |
| DTG |
0.0472
|
0.0470
|
| 3TC |
0.0407
|
0.0400
|
| Title | Lambda z of DTG and 3TC in in the Fasted State: Part 2 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed (represented by n= X,X in the category titles). |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | C: DTG 50 mg/ 3TC 300 mg Bilayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 74 | 74 |
| DTG, n=74,74 |
0.0457
|
0.0469
|
| 3TC, n= 73,74 |
0.0388
|
0.0383
|
| Title | Percentage of Extrapolated AUC (0 to Inf) of DTG and 3TC in the Fasted State: Part 1 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population. |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 73 | 73 |
| DTG |
3.4967
|
3.2582
|
| 3TC |
1.0287
|
0.9052
|
| Title | Percentage of Extrapolated AUC(0 to Inf) of DTG and 3TC in the Fasted State: Part 2 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed indicated by n=X in category titles. |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | C: DTG 50 mg/ 3TC 300 mg Bilayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 74 | 74 |
| DTG, n= 74,74 |
3.8923
|
3.5773
|
| 3TC, n= 73,74 |
1.2518
|
1.1432
|
| Title | AUC of 0 to 24 Hours (AUC[0-24]) of DTG and 3TC in the Fasted State: Part 1 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 73 | 73 |
| DTG |
29.4257
(38.40)
|
37.6112
(30.28)
|
| 3TC |
11.3960
(20.92)
|
11.9418
(20.09)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.2774 | |
| Confidence Interval |
(2-Sided) 90% 1.1931 to 1.3676 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.0475 | |
| Confidence Interval |
(2-Sided) 90% 1.0185 to 1.0773 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma 3TC has been presented. | |
| Title | AUC(0-24) of DTG and 3TC in the Fasted State: Part 2 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | C: DTG 50 mg/ 3TC 300 mg Bilayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 74 | 74 |
| DTG |
31.5664
(37.73)
|
36.6126
(30.93)
|
| 3TC |
11.6419
(20.23)
|
12.5810
(18.50)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.1599 | |
| Confidence Interval |
(2-Sided) 90% 1.0711 to 1.2560 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (C/A) of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.0807 | |
| Confidence Interval |
(2-Sided) 90% 1.0539 to 1.1081 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (C/A) of plasma 3TC has been presented. | |
| Title | Apparent Oral Clearance (CL/F) of DTG and 3TC in the Fasted State: Part 1 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 73 | 73 |
| DTG |
1.1589
(39.29)
|
0.9111
(31.60)
|
| 3TC |
24.3236
(19.88)
|
23.5104
(19.77)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.7868 | |
| Confidence Interval |
(2-Sided) 90% 0.7363 to 0.8408 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.9670 | |
| Confidence Interval |
(2-Sided) 90% 0.9442 to 0.9904 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma 3TC has been presented. | |
| Title | CL/F of DTG and 3TC in the Fasted State: Part 2 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population. Only those participants with data available at the specified time points were analyzed represented by n=X in the category titles. |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | C: DTG 50 mg/ 3TC 300 mg Bilayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 74 | 74 |
| DTG, n= 74, 74 |
1.0584
(40.29)
|
0.9164
(32.12)
|
| 3TC, n= 73, 74 |
23.4901
(18.63)
|
22.1200
(17.94)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.8658 | |
| Confidence Interval |
(2-Sided) 90% 0.8021 to 0.9347 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (C/A) of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.9403 | |
| Confidence Interval |
(2-Sided) 90% 0.9207 to 0.9604 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (C/A) of plasma 3TC has been presented. | |
| Title | Apparent Oral Volume of Distribution (Vz/F) of DTG and 3TC in the Fasted State: Part 1 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 73 | 73 |
| DTG |
24.6254
(37.80)
|
19.3399
(30.05)
|
| 3TC |
616.7365
(34.52)
|
598.8651
(29.07)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.7859 | |
| Confidence Interval |
(2-Sided) 90% 0.7318 to 0.8440 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.9704 | |
| Confidence Interval |
(2-Sided) 90% 0.9157 to 1.0284 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma 3TC has been presented. | |
| Title | Vz/F of DTG and 3TC in the Fasted State: Part 2 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population. Only those participants with data available at the specified data points were analyzed, represented by n= X,X in the category titles. |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | C: DTG 50 mg/ 3TC 300 mg Bilayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 74 | 74 |
| DTG, n= 74, 74 |
23.1159
(37.18)
|
19.8124
(32.73)
|
| 3TC, n= 73, 74 |
650.7952
(35.55)
|
599.5525
(34.28)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.8571 | |
| Confidence Interval |
(2-Sided) 90% 0.7914 to 0.9282 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (C/A) of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.9153 | |
| Confidence Interval |
(2-Sided) 90% 0.8613 to 0.9728 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (C/A) of plasma 3TC has been presented. | |
| Title | Concentration at 24 Hours Post-dose (C24) of DTG and 3TC in the Fasted State: Part 1 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population. |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 73 | 73 |
| DTG |
0.6373
(40.18)
|
0.8059
(32.77)
|
| 3TC |
0.0331
(32.13)
|
0.0318
(31.81)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.2632 | |
| Confidence Interval |
(2-Sided) 90% 1.1811 to 1.3511 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.9598 | |
| Confidence Interval |
(2-Sided) 90% 0.9268 to 0.9941 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma 3TC has been presented. | |
| Title | C24 of DTG and 3TC in the Fasted State: Part 2 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | C: DTG 50 mg/ 3TC 300 mg Bilayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 74 | 74 |
| DTG |
0.7065
(41.48)
|
0.8071
(33.83)
|
| 3TC |
0.0366
(30.39)
|
0.0350
(31.19)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.1425 | |
| Confidence Interval |
(2-Sided) 90% 1.0597 to 1.2317 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (C/A) of plasma DTG has been presented. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.9548 | |
| Confidence Interval |
(2-Sided) 90% 0.9299 to 0.9804 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (C/A) of plasma 3TC has been presented. | |
| Title | Last Quantifiable Concentration (Clast) of DTG and 3TC in the Fasted State: Part 1 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of monolayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 73 | 73 |
| DTG |
0.0702
(58.85)
|
0.0832
(56.42)
|
| 3TC |
0.0056
(43.03)
|
0.0050
(37.58)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.1839 | |
| Confidence Interval |
(2-Sided) 90% 1.0921 to 1.2834 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.8874 | |
| Confidence Interval |
(2-Sided) 90% 0.8340 to 0.9443 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma 3TC has been presented | |
| Title | Clast of DTG and 3TC in the Fasted State: Part 2 |
|---|---|
| Description | Blood samples were collected at indicated time points to study the PK profile of DTG and 3TC when administered as FDC tablet compared to co-administration of separate tablet formulations of DTG and 3TC in fasted state. The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. PK parameters of bilayer FDC tablet formulation of DTG and 3TC was evaluated under fasted condition in Periods 1 and 2 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter BE Summary Population |
| Arm/Group Title | A: DTG 50 mg + EPIVIR 300 mg | C: DTG 50 mg/ 3TC 300 mg Bilayer FDC |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. |
| Measure Participants | 74 | 74 |
| DTG |
0.0800
(66.94)
|
0.0862
(65.26)
|
| 3TC |
0.0069
(47.83)
|
0.0062
(41.60)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.0780 | |
| Confidence Interval |
(2-Sided) 90% 0.9958 to 1.1670 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.9049 | |
| Confidence Interval |
(2-Sided) 90% 0.8474 to 0.9663 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (B/A) of plasma 3TC has been presented | |
| Title | AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 1 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter food effect (FD) Summary Population comprised of participants who participated in the food effect part of the study and had evaluable PK parameters for both fed and fasted administration of the FDC tablet formulation. |
| Arm/Group Title | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Bfed: DTG 50 mg/3TC 300 mg Monolayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. |
| Measure Participants | 16 | 16 |
| DTG |
62.3435
(32.34)
|
71.9777
(19.99)
|
| 3TC |
13.4357
(21.02)
|
12.8668
(18.50)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.1545 | |
| Confidence Interval |
(2-Sided) 90% 1.0208 to 1.3058 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Bfed/B) of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.9577 | |
| Confidence Interval |
(2-Sided) 90% 0.9126 to 1.0049 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Bfed/B) of plasma 3TC has been presented | |
| Title | AUC (0-Inf) of Plasma DTG and 3TC in the Fed State: Part 2 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 16 | 16 |
| DTG |
57.6561
(35.93)
|
76.4283
(22.36)
|
| 3TC |
14.6420
(18.50)
|
13.3443
(20.34)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.3256 | |
| Confidence Interval |
(2-Sided) 90% 1.1837 to 1.4845 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Cfed/C) of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.9114 | |
| Confidence Interval |
(2-Sided) 90% 0.8658 to 0.9593 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Cfed/C) of plasma 3TC has been presented | |
| Title | AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 1 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. |
| Measure Participants | 16 | 16 |
| DTG |
60.3212
(31.78)
|
69.2560
(18.92)
|
| 3TC |
13.2818
(20.90)
|
12.6491
(18.63)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.1481 | |
| Confidence Interval |
(2-Sided) 90% 1.0154 to 1.2982 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Bfed/B) of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.9524 | |
| Confidence Interval |
(2-Sided) 90% 0.9086 to 0.9983 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Bfed/B) of plasma 3TC has been presented | |
| Title | AUC (0-t) of Plasma DTG and 3TC in the Fed State: Part 2 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 16 | 16 |
| DTG |
55.2176
(35.33)
|
72.7545
(20.22)
|
| 3TC |
14.4706
(18.72)
|
13.0923
(20.57)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.3176 | |
| Confidence Interval |
(2-Sided) 90% 1.1750 to 1.4775 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Cfed/C) of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.9048 | |
| Confidence Interval |
(2-Sided) 90% 0.8592 to 0.9528 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Cfed/C) of plasma 3TC has been presented | |
| Title | Cmax of Plasma DTG and 3TC in the Fed State: Part 1 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. |
| Measure Participants | 16 | 16 |
| DTG |
3.5068
(30.27)
|
3.7900
(20.97)
|
| 3TC |
3.5413
(27.14)
|
2.5132
(18.74)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.0808 | |
| Confidence Interval |
(2-Sided) 90% 0.9527 to 1.2261 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Bfed/B) of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.7097 | |
| Confidence Interval |
(2-Sided) 90% 0.6474 to 0.7779 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Bfed/B) of plasma 3TC has been presented | |
| Title | Cmax of Plasma DTG and 3TC in the Fed State: Part 2 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 16 | 16 |
| DTG |
3.1015
(35.62)
|
3.7516
(21.31)
|
| 3TC |
3.5824
(35.18)
|
2.4453
(33.88)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.2096 | |
| Confidence Interval |
(2-Sided) 90% 1.0521 to 1.3908 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Cfed/C) of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.6826 | |
| Confidence Interval |
(2-Sided) 90% 0.5861 to 0.7950 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Cfed/C) of plasma 3TC has been presented | |
| Title | Tlag of DTG and 3TC in Fed State: Part 1 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. |
| Measure Participants | 16 | 16 |
| DTG |
0.0000
|
0.2522
|
| 3TC |
0.0000
|
0.0000
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 0.254 | |
| Confidence Interval |
(2-Sided) 90% 0.250 to 0.378 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 0.125 | |
| Confidence Interval |
(2-Sided) 90% 0.000 to 0.127 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma 3TC has been presented | |
| Title | Tlag of DTG and 3TC in Fed State: Part 2 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 16 | 16 |
| DTG |
0.0000
|
0.1253
|
| 3TC |
0.0000
|
0.0000
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 0.126 | |
| Confidence Interval |
(2-Sided) 90% 0.000 to 0.250 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 0.000 | |
| Confidence Interval |
(2-Sided) 90% 0.000 to 0.125 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma 3TC has been presented | |
| Title | Tmax of DTG and 3TC in the Fed State: Part 1 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. |
| Measure Participants | 16 | 16 |
| DTG |
1.5013
|
5.0006
|
| 3TC |
1.0001
|
3.5003
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 3.017 | |
| Confidence Interval |
(2-Sided) 90% 1.872 to 4.496 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 2.113 | |
| Confidence Interval |
(2-Sided) 90% 1.500 to 2.751 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma 3TC has been presented | |
| Title | Tmax of DTG and 3TC in the Fed State: Part 2 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 16 | 16 |
| DTG |
1.5007
|
5.0019
|
| 3TC |
1.0003
|
2.7508
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 2.500 | |
| Confidence Interval |
(2-Sided) 90% 1.748 to 3.751 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 1.503 | |
| Confidence Interval |
(2-Sided) 90% 0.998 to 2.252 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma 3TC has been presented | |
| Title | T1/2 of DTG and 3TC in the Fed State: Part 1 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. |
| Measure Participants | 16 | 16 |
| DTG |
14.5843
|
14.5816
|
| 3TC |
18.3614
|
19.8579
|
| Title | T1/2 of DTG and 3TC in the Fed State: Part 2 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 16 | 16 |
| DTG |
14.9828
|
15.1718
|
| 3TC |
17.2250
|
19.7311
|
| Title | Lambda z of DTG and 3TC in in the Fed State: Part 1 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. |
| Measure Participants | 16 | 16 |
| DTG |
0.0475
|
0.0475
|
| 3TC |
0.0378
|
0.0349
|
| Title | Lambda z of DTG and 3TC in in the Fed State: Part 2 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 16 | 16 |
| DTG |
0.0463
|
0.0457
|
| 3TC |
0.0403
|
0.0351
|
| Title | Clast of DTG and 3TC in in the Fed State: Part 1 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. |
| Measure Participants | 16 | 16 |
| DTG |
0.1060
|
0.1190
|
| 3TC |
0.0048
|
0.0066
|
| Title | Clast of DTG and 3TC in in the Fed State: Part 2 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 16 | 16 |
| DTG |
0.0975
|
0.1310
|
| 3TC |
0.0059
|
0.0091
|
| Title | Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 1 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. |
| Measure Participants | 16 | 16 |
| DTG |
3.3305
|
3.8870
|
| 3TC |
0.8856
|
1.4830
|
| Title | Percentage of Extrapolated AUC (0-inf) in the Fed State: Part 2 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 16 | 16 |
| DTG |
3.6835
|
3.8790
|
| 3TC |
1.0443
|
1.7467
|
| Title | AUC(0-24) of DTG and 3TC in the Fed State: Part 1 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. |
| Measure Participants | 16 | 16 |
| DTG |
43.1879
(29.88)
|
46.8555
(16.95)
|
| 3TC |
12.6113
(21.25)
|
11.8076
(18.71)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.0849 | |
| Confidence Interval |
(2-Sided) 90% 0.9613 to 1.2245 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Bfed/B) of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.9363 | |
| Confidence Interval |
(2-Sided) 90% 0.8913 to 0.9836 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Bfed/B) of plasma 3TC has been presented | |
| Title | AUC(0-24) of DTG and 3TC in the Fed State: Part 2 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 16 | 16 |
| DTG |
38.6325
(34.53)
|
48.2012
(15.53)
|
| 3TC |
13.7012
(19.24)
|
12.1065
(21.09)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 1.2477 | |
| Confidence Interval |
(2-Sided) 90% 1.1013 to 1.4136 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | 0.8836 | |
| Confidence Interval |
(2-Sided) 90% 0.8351 to 0.9350 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Median Difference of plasma 3TC has been presented | |
| Title | CL/F of DTG and 3TC in the Fed State: Part 1 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. |
| Measure Participants | 16 | 16 |
| DTG |
0.8020
(32.34)
|
0.6947
(19.99)
|
| 3TC |
22.3285
(21.02)
|
23.3159
(18.50)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.8661 | |
| Confidence Interval |
(2-Sided) 90% 0.7658 to 0.9796 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Bfed/B) of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.0442 | |
| Confidence Interval |
(2-Sided) 90% 0.9951 to 1.0957 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Bfed/B) of plasma 3TC has been presented | |
| Title | CL/F of DTG and 3TC in the Fed State: Part 2 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 16 | 16 |
| DTG |
0.8672
(35.93)
|
0.6542
(22.36)
|
| 3TC |
20.4890
(18.50)
|
22.4815
(20.34)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.7544 | |
| Confidence Interval |
(2-Sided) 90% 0.6736 to 0.8448 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Cfed/C) of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.0972 | |
| Confidence Interval |
(2-Sided) 90% 1.0424 to 1.1550 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Cfed/C) of plasma 3TC has been presented | |
| Title | Tlast of DTG and 3TC in the Fed State: Part 1 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. |
| Measure Participants | 16 | 16 |
| DTG |
71.8265
|
71.9758
|
| 3TC |
71.8265
|
71.9758
|
| Title | Tlast of DTG and 3TC in the Fed State: Part 2 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 16 | 16 |
| DTG |
72.0292
|
71.8711
|
| 3TC |
72.0292
|
71.8711
|
| Title | Vz/F of DTG and 3TC in the Fed State: Part 1 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population. |
| Arm/Group Title | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. |
| Measure Participants | 16 | 16 |
| DTG |
16.7520
(28.45)
|
14.4964
(15.87)
|
| 3TC |
593.2054
(29.23)
|
643.0977
(41.08)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.8654 | |
| Confidence Interval |
(2-Sided) 90% 0.7629 to 0.9816 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Bfed/B) of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.0841 | |
| Confidence Interval |
(2-Sided) 90% 0.9139 to 1.2860 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Bfed/B) of plasma 3TC has been presented | |
| Title | Vz/F of DTG and 3TC in the Fed State: Part 2 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 16 | 16 |
| DTG |
19.0954
(36.45)
|
14.6215
(11.63)
|
| 3TC |
535.8125
(35.63)
|
641.3744
(32.10)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 0.7657 | |
| Confidence Interval |
(2-Sided) 90% 0.6702 to 0.8749 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Cfed/C) of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.1970 | |
| Confidence Interval |
(2-Sided) 90% 1.0869 to 1.3182 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Cfed/C) of plasma 3TC has been presented | |
| Title | C24 of DTG and 3TC in the Fed State: Part 1 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC monolayer FDC tablet formulations was assessed in Period 3 of Part 1. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. |
| Measure Participants | 16 | 16 |
| DTG |
0.9216
(36.08)
|
1.1916
(25.03)
|
| 3TC |
0.0304
(33.07)
|
0.0366
(35.90)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.2929 | |
| Confidence Interval |
(2-Sided) 90% 1.1281 to 1.4819 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Bfed/B) of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.2015 | |
| Confidence Interval |
(2-Sided) 90% 1.1074 to 1.3036 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Bfed/B) of plasma 3TC has been presented | |
| Title | C24 of DTG and 3TC in the Fed State: Part 2 |
|---|---|
| Description | Blood samples for PK analysis of DTG and 3TC were collected at given time points to study the PK profile of DTG and 3TC FDC tablet(s). The 4-hour post-dose sample was drawn prior to the participant's first post-dose meal. At each time point, 2 mL of blood was collected. The effect of food on DTG and 3TC bilayer FDC tablet formulations was assessed in Period 3 of Part 2. |
| Time Frame | Pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 16, 24, 48 and 72 hours post-dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| PK Parameter FD Summary Population |
| Arm/Group Title | C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 16 | 16 |
| DTG |
0.8355
(38.46)
|
1.2273
(25.73)
|
| 3TC |
0.0350
(39.91)
|
0.0417
(38.62)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.4690 | |
| Confidence Interval |
(2-Sided) 90% 1.3009 to 1.6588 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Cfed/C) of plasma DTG has been presented | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | A: DTG 50 mg + EPIVIR 300 mg, B: DTG 50 mg/ 3TC 300 mg Monolayer FDC |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio |
| Estimated Value | 1.1935 | |
| Confidence Interval |
(2-Sided) 90% 1.1142 to 1.2785 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Ratio (Cfed/C) of plasma 3TC has been presented | |
| Title | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Part 1 and 2 |
|---|---|
| Description | SBP and DBP were measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for SBP and DBP for Part 1 and 2 is presented. |
| Time Frame | Up to Day 31 in Part 1 and Part 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X,X,X in the category titles. |
| Arm/Group Title | Part 1- A: DTG 50 mg + EPIVIR 300 mg | Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Part 2- A: DTG 50 mg + EPIVIR 300 mg | Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 75 | 76 | 16 | 75 | 75 | 16 |
| DBP,4 hour,n=75,76,16,75,75,16 |
0.1
(5.85)
|
0.2
(5.24)
|
-2.1
(4.19)
|
-0.5
(4.09)
|
-0.3
(5.71)
|
0.0
(4.86)
|
| DBP,Day 2,n=74,75,16,75,75,16 |
-0.3
(5.53)
|
-0.9
(6.14)
|
0.4
(5.32)
|
-1.7
(4.87)
|
-1.1
(4.99)
|
3.1
(5.37)
|
| DBP,Day 3,n=74,75,16,75,75,16 |
3.2
(6.83)
|
2.7
(5.95)
|
1.3
(5.19)
|
1.7
(5.74)
|
1.2
(6.09)
|
3.4
(5.76)
|
| DBP,Day 4,n=73,75,16,75,75,16 |
7.4
(6.47)
|
5.4
(6.64)
|
6.1
(4.22)
|
4.9
(6.51)
|
5.3
(6.11)
|
8.3
(6.94)
|
| SBP,4 hour,n=75,76,16,75,75,16 |
1.5
(6.12)
|
0.6
(5.94)
|
-0.8
(5.49)
|
0.0
(5.04)
|
0.5
(7.21)
|
1.0
(7.28)
|
| SBP,Day 2,n=74,75,16,75,75,16 |
-0.5
(6.88)
|
-1.4
(6.05)
|
0.4
(3.91)
|
-1.5
(5.10)
|
-1.7
(7.12)
|
1.9
(8.06)
|
| SBP,Day 3,n=74,75,16,75,75,16 |
4.0
(6.67)
|
2.7
(6.15)
|
2.9
(4.84)
|
1.9
(7.28)
|
1.6
(7.50)
|
2.3
(7.73)
|
| SBP,Day 4,n=73,75,16,75,75,16 |
8.2
(8.09)
|
7.5
(8.43)
|
7.0
(5.80)
|
7.0
(8.86)
|
7.2
(8.72)
|
7.6
(8.42)
|
| Title | Change From Baseline in Heart Rate (HR): Part 1 and 2 |
|---|---|
| Description | HR was measured in the supine or semi-supine position after 5 minutes rest. The Baseline value was considered to be the participant's last available assessment prior to time of the first dose. Change from Baseline was defined as post dose visit value minus Baseline value. Data for HR for Part 1 and 2 is presented. |
| Time Frame | Up to Day 31 in Part 1 and Part 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. Only those participants available at the specified time points were analyzed represented by n=X,X,X,X,X,X in the category titles. |
| Arm/Group Title | Part 1- A: DTG 50 mg + EPIVIR 300 mg | Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Part 2- A: DTG 50 mg + EPIVIR 300 mg | Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 75 | 76 | 16 | 75 | 75 | 16 |
| 4 hour,n=75,76,16,75,75,16 |
0.6
(5.49)
|
0.4
(4.25)
|
4.9
(3.84)
|
0.1
(5.25)
|
-0.3
(5.43)
|
3.0
(3.22)
|
| Day 2,n=74,75,16,75,75,16 |
2.2
(5.53)
|
1.9
(4.60)
|
2.9
(4.17)
|
1.6
(5.48)
|
0.6
(5.74)
|
1.6
(5.44)
|
| Day 3,n=74,75,16,75,75,16 |
5.1
(8.15)
|
6.0
(6.35)
|
5.8
(6.80)
|
5.3
(7.23)
|
3.8
(7.13)
|
7.7
(10.42)
|
| Day 4,n=73,75,16,75,75,16 |
7.5
(9.28)
|
8.9
(7.68)
|
9.6
(9.15)
|
8.9
(8.31)
|
6.1
(8.39)
|
9.5
(10.10)
|
| Title | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1 and 2 |
|---|---|
| Description | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. Participants having any AE or SAE are presented. |
| Time Frame | Up to Week 11 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population. |
| Arm/Group Title | Part 1- A: DTG 50 mg + EPIVIR 300 mg | Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Part 2- A: DTG 50 mg + EPIVIR 300 mg | Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. |
| Measure Participants | 75 | 76 | 16 | 75 | 75 | 16 |
| AEs |
14
17.9%
|
18
23.7%
|
1
0.6%
|
15
NaN
|
12
NaN
|
1
NaN
|
| SAEs |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
Adverse Events
| Time Frame | AEs and SAEs were collected from the start of study treatment until the follow-up contact (Up to 11 weeks) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety Population comprised of all participants who were enrolled in the study and received at least one dose of study drug. | |||||||||||
| Arm/Group Title | Part 1- A: DTG 50 mg + EPIVIR 300 mg | Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Part 2- A: DTG 50 mg + EPIVIR 300 mg | Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | ||||||
| Arm/Group Description | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 1. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation in Periods 1 and 2 of Part 1. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received DTG 50 mg and 3TC 300 mg monolayer FDC tablet formulation (Product Code AH). Treatment was administered with high fat meal. There was a washout period of at least 7 days (-4 hours) between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and EPIVIR 300 mg tablet(s) at the same time with 240 mL of water in Periods 1 and 2 of Part 2. Treatments were administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation in Periods 1 and 2 of Part 2. Treatment was administered in the fasted state after at least 10 hours of fasting. There was a washout period of at least 7 days between each dose of the study drug. | Participants received a single oral dose of DTG 50 mg and 3TC 300 mg bilayer FDC tablet formulation along with a high fat meal in Period 3 of Part 2. | ||||||
All Cause Mortality |
||||||||||||
| Part 1- A: DTG 50 mg + EPIVIR 300 mg | Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Part 2- A: DTG 50 mg + EPIVIR 300 mg | Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/75 (0%) | 0/76 (0%) | 0/16 (0%) | 0/75 (0%) | 0/75 (0%) | 0/16 (0%) | ||||||
Serious Adverse Events |
||||||||||||
| Part 1- A: DTG 50 mg + EPIVIR 300 mg | Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Part 2- A: DTG 50 mg + EPIVIR 300 mg | Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/75 (0%) | 0/76 (0%) | 0/16 (0%) | 0/75 (0%) | 0/75 (0%) | 0/16 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| Part 1- A: DTG 50 mg + EPIVIR 300 mg | Part 1- B: DTG 50 mg/ 3TC 300 mg Monolayer FDC | Part 1-Bfed: DTG 50 mg and 3TC 300 mg Monolayer FDC Fed | Part 2- A: DTG 50 mg + EPIVIR 300 mg | Part 2-C: DTG 50 mg and 3TC 300 mg Bilayer FDC | Part 2-Cfed: DTG 50 mg and 3TC 300 mg Bilayer FDC Fed | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/75 (2.7%) | 5/76 (6.6%) | 1/16 (6.3%) | 8/75 (10.7%) | 6/75 (8%) | 1/16 (6.3%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Contusion | 0/75 (0%) | 0/76 (0%) | 0/16 (0%) | 0/75 (0%) | 0/75 (0%) | 1/16 (6.3%) | ||||||
| Skin abrasion | 0/75 (0%) | 0/76 (0%) | 0/16 (0%) | 0/75 (0%) | 0/75 (0%) | 1/16 (6.3%) | ||||||
| Nervous system disorders | ||||||||||||
| Headache | 2/75 (2.7%) | 5/76 (6.6%) | 1/16 (6.3%) | 8/75 (10.7%) | 6/75 (8%) | 0/16 (0%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
| GSKClinicalSupportHD@gsk.com |
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT03078556
Other Study ID Numbers:
- 204994
First Posted:
Mar 13, 2017
Last Update Posted:
Feb 21, 2019
Last Verified:
Aug 1, 2018