A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin Extended Release Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate bioequivalence of the metformin component of the Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet coadministered with canagliflozin in healthy fed and fasted participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Sequence ADBC Participants will receive Treatment A (1 canagliflozin tablet 100 milligram (mg) and 1 canagliflozin tablet 50 mg along with two Extended Release (XR) tablets of metformin of each 500 mg orally under fed condition) on Day 1 of treatment period 1, then Treatment D (1 Extended Release (XR) fixed dose combination [FDC] tablet containing canagliflozin 150 mg and metformin 1000 mg orally under fasted condition) on Day 1 of treatment period 2, then Treatment B (1 XR FDC tablet containing canagliflozin 150 mg and metformin 1000 mg orally under fed condition) on Day 1 of treatment period 3, followed by Treatment C (1 canagliflozin tablet 50 mg and 1 canagliflozin tablet 100 mg and metformin XR two tablets of each 500 mg orally under fasted condition) on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period. |
Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]
Participants will receive 1 XR FDC tablet containing canagliflozin 150 mg and metformin 1000 mg orally under fed (Treatment B)or fasted condition (Treatment D) in a given treatment period as per treatment sequence.
Drug: Canagliflozin
Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablets) under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
Drug: Canagliflozin
Participants will receive canagliflozin 100 mg oral tablet under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
Drug: Metformin Extended Release (XR)
Participants will receive metformin XR 500 mg tablet orally under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
|
| Experimental: Treatment Sequence BACD Participants will receive Treatment B on Day 1 of treatment period 1, then Treatment A on Day 1 of treatment period 2, then Treatment C on Day 1 of treatment period 3, followed by Treatment D on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period. |
Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]
Participants will receive 1 XR FDC tablet containing canagliflozin 150 mg and metformin 1000 mg orally under fed (Treatment B)or fasted condition (Treatment D) in a given treatment period as per treatment sequence.
Drug: Canagliflozin
Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablets) under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
Drug: Canagliflozin
Participants will receive canagliflozin 100 mg oral tablet under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
Drug: Metformin Extended Release (XR)
Participants will receive metformin XR 500 mg tablet orally under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
|
| Experimental: Treatment Sequence CBDA Participants will receive Treatment C Day 1 of treatment period 1, then Treatment B on Day 1 of treatment period 2, then Treatment D on Day 1 of treatment period 3, followed by Treatment A on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period. |
Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]
Participants will receive 1 XR FDC tablet containing canagliflozin 150 mg and metformin 1000 mg orally under fed (Treatment B)or fasted condition (Treatment D) in a given treatment period as per treatment sequence.
Drug: Canagliflozin
Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablets) under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
Drug: Canagliflozin
Participants will receive canagliflozin 100 mg oral tablet under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
Drug: Metformin Extended Release (XR)
Participants will receive metformin XR 500 mg tablet orally under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
|
| Experimental: Treatment Sequence DCAB Participants will receive Treatment D on Day 1 of treatment period 1, then Treatment C on Day 1 of treatment period 2, then Treatment A on Day 1 of treatment period 3, followed by Treatment B on Day 1 of treatment period 4. A washout period of 7 days will be maintained between each treatment period. |
Drug: Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]
Participants will receive 1 XR FDC tablet containing canagliflozin 150 mg and metformin 1000 mg orally under fed (Treatment B)or fasted condition (Treatment D) in a given treatment period as per treatment sequence.
Drug: Canagliflozin
Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablets) under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
Drug: Canagliflozin
Participants will receive canagliflozin 100 mg oral tablet under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
Drug: Metformin Extended Release (XR)
Participants will receive metformin XR 500 mg tablet orally under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) of Metformin [Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr post-dose on Day 1; 24 hr postdose on Day 2]
The Cmax is the maximum observed plasma concentration of metformin.
- Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Observed Quantifiable Concentration (AUClast) of Metformin [Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr post dose on Day 1; 24 hr post-dose on Day 2]
The area under the plasma concentration time curve from time 0 to the time of the last observed quantifiable concentration (Clast).
- Area Under the Plasma Concentration Time Curve From Time 0 to Infinite Time [AUC (0-infinity)] of Metformin [Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, hr post dose on Day 1; 24 hr postdose on Day 2]
The AUC (0-infinity) is the area under the plasma concentration time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Secondary Outcome Measures
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [Day 1 to End of study (up to 58 Days)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
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Before randomization, a woman must be either Not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception (failure rate of less than [<]1 percent [%] per year when used consistently and correctly) throughout the study
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All women must have a negative urine pregnancy test at Screening and on Day -1 of each Treatment Period
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Body mass index (BMI) (weight [kg]/height^2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
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Blood pressure (an average of 3 measurements done after the participant is sitting for 5 minutes and with at least 5 minutes between measurements) between 90 and 140 (mercury of millimeter) mmHg, inclusive, systolic and no higher than 90 mmHg diastolic at Screening or Day -1 of each Treatment Period
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Normal renal function evidenced by estimated glomerular filtration rate (eGFR) greater than or equal to (>=90) milliliters per minute (mL/min)/1.73m^2 using the Modification of Diet in Renal Disease Study (MDRD) equation as defined in the protocol
Exclusion Criteria:
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History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
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Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis as assessed by the investigator at Screening or Day -1 of the first Treatment Period
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Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) (Screening only) as assessed by the investigator at Screening or on Day -1 of the first Treatment Period as deemed appropriate by the investigator
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Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, hormonal contraceptives and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
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History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tempe | Arizona | United States |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108201
- 28431754DIA1076