A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02014272
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Days): 30
• Patients Per Site Per Month: 28.4

Study Details

Study Description

Brief Summary

This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: RIN 150; Drug: reference drugs	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: An Open Label, Single Dose, 2-Way Cross-Over Randomized Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 (Contains 150 Mg Rifampicin And 75 Mg Isoniazid Per Tablet) To An Equivalent Dose Of Single Drug Reference Preparations Of Rifampicin And Isoniazid Following Oral Administration In Healthy Adults Under Fasting Conditions
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test RIN 150 contains 150 rifampicin and 75 mg isoniazid	Drug: RIN 150; Each subject will receive a single oral dose of 4 fixed dose combination tablets (RIN 150) each contains 150 rifampicin and 75 mg isoniazid.
Active Comparator: Reference Individual references of rifampicin and isoniazid	Drug: reference drugs; Each subject will receive a single oral dose of 4 x 150 mg rifampicin capsules and 3 x 100 mg isoniazid capsules.

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1]

   Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) was reported for rifampicin and isoniazid.

2. Maximum Observed Plasma Concentration (Cmax) [0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1]

   Cmax was reported for rifampicin and isoniazid.

Secondary Outcome Measures

1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1]

   AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) was reported for rifampicin and isoniazid. It is obtained from AUC (0 - t) plus AUC (t - ∞).

2. Plasma Decay Half-Life (t1/2) [0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1]

   Plasma decay half life (t1/2) was reported for rifampicin and isoniazid.

3. Time to Reach Maximum Observed Plasma Concentration (Tmax) [0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1]

   Tmax was reported for rifampicin and isoniazid.

Other Outcome Measures

1. Number of Participants With Clinically Significant Changes in Vital Signs [Screening up to Day 2 of intervention period 2]

   Criteria for clinical significant change in vital signs: systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg), diastolic BP <50 mmHg, supine and sitting heart rate <40 beats per minute (bpm) or greater than (>) 120 bpm, standing and erect heart rate <40 bpm or >140 bpm. Maximum change from baseline in systolic BP >=30 mmHg, maximum change from baseline in diastolic BP >=20 mmHg. Participants who met the criteria were reported.

2. Number of Participants With Laboratory Test Abnormalities [Screening up to Day 2 of intervention period 2]

   Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/ greater than [>] 1.5*limit of reference range [LRR]); platelets (<0.5/>1.75*LRR); neutrophils, lymphocytes (<0.8/>1.2*LRR); eosinophils, basophils, monocytes (>1.2*upper LN [ULN]); bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN); creatinine, urea (>1.3*ULN); fasting glucose (<0.6 />1.5*LRR); uric acid (>1.2*ULN); sodium (<0.95/>1.05*LRR); potassium, calcium, chloride, bicarbonate (<0.9/>1.1*LRR); albumin, total protein (<0.8/>1.2*LRR); creatine kinase (>2.0*ULN); urine red blood cells (RBCs), urine white blood cells (WBCs) (>=20 high-powered field). Total number of participants with any laboratory abnormalities was reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male or female, 21 to 55 years of age, body weight no less than 55 kg, with a signed and dated informed consent document and is willing and able to comply with all scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), positive Hepatitis B surface antigen or HIV serology results;

• Pregnant or nursing female;

• History or active tuberculosis;

• Participated in investigational drug studies within 3 months;

• Used prescription or nonprescription drugs within 7 days or 5 half-lives.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Singapore		Singapore	188770

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02014272
• Other Study ID Numbers: B3801003
• First Posted: Dec 18, 2013
• Last Update Posted: Jul 16, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Pfizer: Bioequivalence; RIN 150; Healthy volunteers

Study Results

Participant Flow

Arm/Group Title	RIN 150 First, Then Rifampicin and Isoniazid	Rifampicin and Isoniazid First, Then RIN 150
Arm/Group Description	Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contained 150 milligram [mg] rifampicin and 75 mg isoniazid) on Day 1 in first intervention period, followed by single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in second intervention period. A washout period of at least 7 days was maintained between each intervention period.	Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in first intervention period followed by single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in second intervention period. A washout period of at least 7 days was maintained between each intervention period.
Period Title: Intervention Period 1
STARTED	14	14
COMPLETED	13	13
NOT COMPLETED	1	1
Period Title: Intervention Period 1
STARTED	13	13
COMPLETED	13	13
NOT COMPLETED	0	0
Period Title: Intervention Period 1
STARTED	13	13
COMPLETED	13	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	Includes all participants randomized to receive RIN 150 first and rifampicin and isoniazid first.
Overall Participants	28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.5 (7.1)
Sex: Female, Male (Count of Participants)
Female	1 3.6%
Male	27 96.4%

Outcome Measures

1. Primary Outcome

Title	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Description	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) was reported for rifampicin and isoniazid.
Time Frame	0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1

Outcome Measure Data

Analysis Population Description

Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest.

Arm/Group Title	RIN 150	Rifampicin and Isoniazid
Arm/Group Description	Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.	Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
Measure Participants	27	27
AUClast: Rifampicin	85020 (20)	90030 (24)
AUClast: Isoniazid	16220 (79)	16120 (77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RIN 150, Rifampicin and Isoniazid
	Comments	Natural log transformed AUClast of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of adjusted geometric means
	Estimated Value	95.45
	Confidence Interval	(2-Sided) 90%; 92.07 to 98.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	RIN 150, Rifampicin and Isoniazid
	Comments	Natural log transformed AUClast of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of adjusted geometric means
	Estimated Value	103.45
	Confidence Interval	(2-Sided) 90%; 99.33 to 107.75
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Maximum Observed Plasma Concentration (Cmax)
Description	Cmax was reported for rifampicin and isoniazid.
Time Frame	0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1

Outcome Measure Data

Analysis Population Description

Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest.

Arm/Group Title	RIN 150	Rifampicin and Isoniazid
Arm/Group Description	Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.	Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
Measure Participants	27	27
Cmax: Rifampicin	13670 (21)	15000 (28)
Cmax: Isoniazid	6080 (45)	5577 (37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RIN 150, Rifampicin and Isoniazid
	Comments	Natural log transformed Cmax of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of adjusted geometric means
	Estimated Value	91.63
	Confidence Interval	(2-Sided) 90%; 83.13 to 101.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	RIN 150, Rifampicin and Isoniazid
	Comments	Natural log transformed Cmax of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of adjusted geometric means
	Estimated Value	107.58
	Confidence Interval	(2-Sided) 90%; 96.07 to 120.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
Description	AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) was reported for rifampicin and isoniazid. It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time Frame	0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1

Outcome Measure Data

Analysis Population Description

Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, n=participants in the treatment group who were evaluable for this measure for specified drug of each group with reportable AUC (0 - ∞) values, respectively.

Arm/Group Title	RIN 150	Rifampicin and Isoniazid
Arm/Group Description	Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.	Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
Measure Participants	27	27
AUC (0 - ∞): Rifampicin (n=27, 27)	86670 (21)	91340 (24)
AUC (0 - ∞): Isoniazid (n=27, 26)	16680 (78)	17390 (71)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RIN 150, Rifampicin and Isoniazid
	Comments	Natural log transformed AUC(0 - ∞) of rifampicin was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of adjusted geometric means
	Estimated Value	95.92
	Confidence Interval	(2-Sided) 90%; 92.54 to 99.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	RIN 150, Rifampicin and Isoniazid
	Comments	Natural log transformed AUC(0 - ∞) of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of adjusted geometric means
	Estimated Value	102.41
	Confidence Interval	(2-Sided) 90%; 98.76 to 106.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Plasma Decay Half-Life (t1/2)
Description	Plasma decay half life (t1/2) was reported for rifampicin and isoniazid.
Time Frame	0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1

Outcome Measure Data

Analysis Population Description

Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, n=participants in the treatment group who were evaluable for this measure for specified drug of each group with reportable t½ values, respectively.

Arm/Group Title	RIN 150	Rifampicin and Isoniazid
Arm/Group Description	Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.	Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
Measure Participants	27	27
t1/2: Rifampicin (n=27, 27)	3.608 (0.89531)	3.572 (0.72948)
t1/2: Isoniazid (n=27, 26)	2.776 (1.4110)	3.000 (1.4375)

5. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax)
Description	Tmax was reported for rifampicin and isoniazid.
Time Frame	0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1

Outcome Measure Data

Analysis Population Description

Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest.

Arm/Group Title	RIN 150	Rifampicin and Isoniazid
Arm/Group Description	Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.	Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
Measure Participants	27	27
Tmax: Rifampicin	1.67	1.67
Tmax: Isoniazid	0.500	0.500

6. Other Pre-specified Outcome

Title	Number of Participants With Clinically Significant Changes in Vital Signs
Description	Criteria for clinical significant change in vital signs: systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg), diastolic BP <50 mmHg, supine and sitting heart rate <40 beats per minute (bpm) or greater than (>) 120 bpm, standing and erect heart rate <40 bpm or >140 bpm. Maximum change from baseline in systolic BP >=30 mmHg, maximum change from baseline in diastolic BP >=20 mmHg. Participants who met the criteria were reported.
Time Frame	Screening up to Day 2 of intervention period 2

Outcome Measure Data

Analysis Population Description

Safety analysis set consisted of all participants who received at least 1 dose of study medication.

Arm/Group Title	RIN 150	Rifampicin and Isoniazid
Arm/Group Description	Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.	Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
Measure Participants	27	27
Number [participants]	0 0%	0 NaN

7. Other Pre-specified Outcome

Title	Number of Participants With Laboratory Test Abnormalities
Description	Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/ greater than [>] 1.5*limit of reference range [LRR]); platelets (<0.5/>1.75*LRR); neutrophils, lymphocytes (<0.8/>1.2*LRR); eosinophils, basophils, monocytes (>1.2*upper LN [ULN]); bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN); creatinine, urea (>1.3*ULN); fasting glucose (<0.6 />1.5*LRR); uric acid (>1.2*ULN); sodium (<0.95/>1.05*LRR); potassium, calcium, chloride, bicarbonate (<0.9/>1.1*LRR); albumin, total protein (<0.8/>1.2*LRR); creatine kinase (>2.0*ULN); urine red blood cells (RBCs), urine white blood cells (WBCs) (>=20 high-powered field). Total number of participants with any laboratory abnormalities was reported.
Time Frame	Screening up to Day 2 of intervention period 2

Outcome Measure Data

Analysis Population Description

Safety analysis set consisted of all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Arm/Group Title	RIN 150	Rifampicin and Isoniazid
Arm/Group Description	Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.	Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
Measure Participants	26	27
Number [participants]	4 14.3%	2 NaN

Adverse Events

Adverse Event Reporting Description	Safety analysis population included all participants who received at least 1 dose of study medication.
Arm/Group Title	RIN 150		Rifampicin and Isoniazid
Arm/Group Description	Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.		Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
All Cause Mortality
	RIN 150		Rifampicin and Isoniazid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	RIN 150		Rifampicin and Isoniazid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	RIN 150		Rifampicin and Isoniazid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	27/27 (100%)		26/27 (96.3%)
Gastrointestinal disorders
Mouth ulceration	1/27 (3.7%)		0/27 (0%)
Nausea	0/27 (0%)		1/27 (3.7%)
General disorders
Catheter site haematoma	0/27 (0%)		2/27 (7.4%)
Catheter site pain	1/27 (3.7%)		1/27 (3.7%)
Fatigue	0/27 (0%)		1/27 (3.7%)
Infections and infestations
Upper respiratory tract infection	1/27 (3.7%)		1/27 (3.7%)
Injury, poisoning and procedural complications
Contusion	1/27 (3.7%)		1/27 (3.7%)
Lip injury	1/27 (3.7%)		1/27 (3.7%)
Nervous system disorders
Headache	1/27 (3.7%)		1/27 (3.7%)
Renal and urinary disorders
Chromaturia	26/27 (96.3%)		25/27 (92.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.