Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01311505
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Days): 30
• Patients Per Site Per Month: 21.3

Study Details

Study Description

Brief Summary

This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2 Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer Inc) with equivalent dose of the reference Rimactane® capsule (each contains 300 mg rifampicin, Novartis Sandoz) in healthy Filipino male subjects. This study also aims to determine the safety and tolerability of Myrin© 2 tablets and Rimactane® capsules in these subjects.

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis	Drug: Myrin© 2 (Rifampicin + Isoniazid); Drug: Rimactane® (Rifampicin)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label, Single Dose, Randomized, Two-Way Cross-Over Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination Rifampicin + Isoniazid (Myrin© 2, Pfizer Inc) Tablet With The Reference Drug (Rimactane®, Novartis Sandoz) Capsule In Healthy Filipino Male Subjects
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A Test	Drug: Myrin© 2 (Rifampicin + Isoniazid); Two (2) fixed-dose combination tablets each containing Rifampicin 150 mg and Isoniazid 75 mg; Other Names: Myrin© 2 (Pfizer Inc.)
Active Comparator: B Reference	Drug: Rimactane® (Rifampicin); One (1) capsule of Rifampicin 300 mg; Other Names: Rimactane® (Novartis Sandoz)

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC [0-t]) [0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hours (hrs) post-dose]

   AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

2. Maximum Observed Plasma Concentration (Cmax) [0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose]

Secondary Outcome Measures

1. Time to Reach Maximum Observed Plasma Concentration (Tmax) [0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose]

2. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞]) [0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose]

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

3. Plasma Decay Half-life (t1/2) [0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose]

   Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

4. Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated) [0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose]

   AUC%extrapolated is the extrapolated area under the plasma concentration time profile following the last measured concentration. It is calculated as (AUC [0-∞] minus AUC[0-10])*100/ AUC (0-∞), where AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-10) = area under the plasma concentration time-curve from zero (pre-dose) to the last quantifiable concentration.

Other Outcome Measures

1. Number of Participants With Abnormal Safety Laboratory Test Values [Screening and Follow-up (1 week post-baseline)]

   Participants were evaluated for following safety laboratory tests: Hematology, chemistry, urinalysis.

2. Clinically Significant Change From Baseline Supine Blood Pressure (BP) [Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)]

   Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.

3. Clinically Significant Change From Baseline Pulse Rate [Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)]

   Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.

4. Clinically Significant Change From Baseline Oral Temperature [Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)]

   Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.

5. Clinically Significant Change From Baseline Respiratory Rate [Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)]

   Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.

6. Number of Participants With Adverse Events (AEs) [Baseline (Day 0), Day 1 and Follow-up (1 week post-baseline)]

   Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male subjects between the ages of 18 and 55 years, inclusive.

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

• An informed consent document signed and dated by the subject.

• Subjects willing and able to comply with 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, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

• Any condition possibly affecting drug absorption (e.g., gastrectomy).

• A positive urine drug screen.

• History of regular alcohol consumption exceeding 21 drinks/week (1 drink = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening.

• Treatment with an investigational drug within 3 months (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.

• 12-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.

• History of previous treatment for TB or is suspected of suffering from TB.

• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal medication, herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen / paracetamol may be used at doses of less than 1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

• Blood donation of approximately 1 pint (500 ml) within 56 days prior to dosing.

• A history of hypersensitivity to any of the study medications or related substances, or to any of the ingredients used in the study drug formulations.

• Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.

• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

• Recent history of diarrhea (2 weeks).

• Recent use of oral (2 weeks) or IV (2-3 months) antibiotics to assure normal bowel flora at study start.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Dasmariñas City		Philippines	4114

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: NCT01311505
• Other Study ID Numbers: B3801001
• First Posted: Mar 9, 2011
• Last Update Posted: Jul 30, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by Pfizer: bioequivalence; rifampicin
• Additional relevant MeSH terms: Tuberculosis; Rifampin; Isoniazid

Study Results

Participant Flow

Pre-assignment Detail	Out of 22 participants enrolled, only 21 participants were randomized since 1 participant withdrew from the study.

Arm/Group Title	Myrin 2 First, Then Rimactane	Rimactane First, Then Myrin 2
Arm/Group Description	Single oral dose of 2 fixed dose combination (FDC) tablets of Myrin 2 (each tablet contains 150 milligram (mg) rifampicin and 75 mg isoniazid) in first intervention period, and single oral dose of Rimactane capsule (300 mg rifampicin) in second intervention period. A washout period of at least 7 days was maintained between each period.	Single oral dose of Rimactane capsule (300 mg rifampicin) in first intervention period; and single oral dose of 2 FDC tablets of Myrin 2 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) in second intervention period. A washout period of at least 7 days was maintained between each period.
Period Title: First Intervention Period
STARTED	10	11
COMPLETED	10	10
NOT COMPLETED	0	1
Period Title: First Intervention Period
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0
Period Title: First Intervention Period
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Participants Eligible for Analysis
Arm/Group Description	Includes participants randomized to receive Myrin 2 first and Rimactane first and who had completed the study. It excludes 1 participant who did not meet the weight requirement for the study (protocol violator).
Overall Participants	20
Age, Customized (participants) [Number]
18 to 22 years	12 60%
23 to 27 years	4 20%
28 to 32 years	2 10%
33 to 37 years	2 10%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	20 100%

Outcome Measures

1. Primary Outcome

Title	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC [0-t])
Description	AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Time Frame	0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hours (hrs) post-dose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	Myrin 2	Rimactane
Arm/Group Description	Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.	Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
Measure Participants	20	20
Geometric Mean (Geometric Coefficient of Variation) [microgram*hour/milliliter (mcg*h/mL)]	38.59 (24.99)	38.81 (21.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Myrin 2, Rimactane
	Comments	20 participants (10 per sequence) provided at least 98% power that 90% confidence interval (CI) for ratio of test to reference for AUC(0-t) of rifampicin lie within acceptance region of 80%-125%. Intra-participant coefficient of variation (CV) estimate of approximately 13.48% for AUC(0-t) was used for this power calculation. Natural log transformed AUC(0-t) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.
	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	98.90
	Confidence Interval	(2-Sided) 90%; 92.98 to 105.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Maximum Observed Plasma Concentration (Cmax)
Time Frame	0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose

Outcome Measure Data

Analysis Population Description

PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	Myrin 2	Rimactane
Arm/Group Description	Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.	Single oral dose of reference drug Rimactane capsule (300 mg capsule) in either first intervention period or second intervention period.
Measure Participants	20	20
Geometric Mean (Geometric Coefficient of Variation) [mcg/mL]	7.89 (24.89)	8.02 (22.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Myrin 2, Rimactane
	Comments	20 participants (10 per sequence) provided at least 94% power that 90% CI for ratio of test to reference for Cmax of rifampicin lie within acceptance region of 80%-125%. Intra-participant CV estimate of approximately 16.43% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as random effect.
	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	98.24
	Confidence Interval	(2-Sided) 90%; 87.77 to 109.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame	0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose

Outcome Measure Data

Analysis Population Description

PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	Myrin 2	Rimactane
Arm/Group Description	Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.	Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
Measure Participants	20	20
Median (Full Range) [hrs]	2.0	1.0

4. 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-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
Time Frame	0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose

Outcome Measure Data

Analysis Population Description

PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	Myrin 2	Rimactane
Arm/Group Description	Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.	Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
Measure Participants	20	20
Geometric Mean (Geometric Coefficient of Variation) [mcg*hr/mL]	47.72 (30.54)	47.15 (25.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Myrin 2, Rimactane
	Comments	Natural log transformed AUC(0-∞) of rifampicin was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
	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	100.25
	Confidence Interval	(2-Sided) 90%; 94.44 to 106.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Plasma Decay Half-life (t1/2)
Description	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame	0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose

Outcome Measure Data

Analysis Population Description

PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	Myrin 2	Rimactane
Arm/Group Description	Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.	Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
Measure Participants	20	20
Mean (Standard Deviation) [hrs]	4.0750 (1.0777)	3.8635 (0.8347)

6. Secondary Outcome

Title	Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated)
Description	AUC%extrapolated is the extrapolated area under the plasma concentration time profile following the last measured concentration. It is calculated as (AUC [0-∞] minus AUC[0-10])*100/ AUC (0-∞), where AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-10) = area under the plasma concentration time-curve from zero (pre-dose) to the last quantifiable concentration.
Time Frame	0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose

Outcome Measure Data

Analysis Population Description

PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.

Arm/Group Title	Myrin 2	Rimactane
Arm/Group Description	Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.	Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
Measure Participants	20	20
Geometric Mean (Geometric Coefficient of Variation) [Percent AUC]	18.84 (38.47)	17.53 (30.23)

7. Other Pre-specified Outcome

Title	Number of Participants With Abnormal Safety Laboratory Test Values
Description	Participants were evaluated for following safety laboratory tests: Hematology, chemistry, urinalysis.
Time Frame	Screening and Follow-up (1 week post-baseline)

Outcome Measure Data

Analysis Population Description

Safety population included participants who received at least 1 dose of study medication.

Arm/Group Title	Myrin 2	Rimactane
Arm/Group Description	Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.	Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
Measure Participants	20	21
Screening	0 0%	0 NaN
Follow-up	0 0%	0 NaN

8. Other Pre-specified Outcome

Title	Clinically Significant Change From Baseline Supine Blood Pressure (BP)
Description	Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.
Time Frame	Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)

Outcome Measure Data

Analysis Population Description

Data was not summarized since supine systolic and diastolic BP remained within normal limits throughout the study and there were no significant deviations from baseline.

Arm/Group Title	Myrin 2	Rimactane
Arm/Group Description	Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.	Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
Measure Participants	0	0

9. Other Pre-specified Outcome

Title	Clinically Significant Change From Baseline Pulse Rate
Description	Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.
Time Frame	Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)

Outcome Measure Data

Analysis Population Description

Data was not summarized since pulse rate remained within normal limits throughout the study and there were no significant deviations from baseline.

Arm/Group Title	Myrin 2	Rimactane
Arm/Group Description	Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.	Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
Measure Participants	0	0

10. Other Pre-specified Outcome

Title	Clinically Significant Change From Baseline Oral Temperature
Description	Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.
Time Frame	Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)

Outcome Measure Data

Analysis Population Description

Data was not summarized since oral temperature remained within normal limits throughout the study and there were no significant deviations from baseline.

Arm/Group Title	Myrin 2	Rimactane
Arm/Group Description	Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.	Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
Measure Participants	0	0

11. Other Pre-specified Outcome

Title	Clinically Significant Change From Baseline Respiratory Rate
Description	Mean change: vital sign value at observation (Day 1 and follow-up) minus vital sign value at baseline.
Time Frame	Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline)

Outcome Measure Data

Analysis Population Description

Data was not summarized since respiratory rate remained within normal limits throughout the study and there were no significant deviations from baseline.

Arm/Group Title	Myrin 2	Rimactane
Arm/Group Description	Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.	Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
Measure Participants	0	0

12. Other Pre-specified Outcome

Title	Number of Participants With Adverse Events (AEs)
Description	Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.
Time Frame	Baseline (Day 0), Day 1 and Follow-up (1 week post-baseline)

Outcome Measure Data

Analysis Population Description

Safety population included participants who received at least 1 dose of study medication.

Arm/Group Title	Myrin 2	Rimactane
Arm/Group Description	Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.	Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
Measure Participants	20	21
Day 0	0 0%	0 NaN
Day 1	0 0%	0 NaN
Follow-up	0 0%	0 NaN

Adverse Events

Arm/Group Title	Myrin 2		Rimactane
Arm/Group Description	Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.		Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
All Cause Mortality
	Myrin 2		Rimactane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Myrin 2		Rimactane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Myrin 2		Rimactane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/21 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.