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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01311505
First received: February 15, 2011
Last updated: June 21, 2012
Last verified: June 2012
Results First Received: March 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Tuberculosis
Interventions: Drug: Myrin© 2 (Rifampicin + Isoniazid)
Drug: Rimactane® (Rifampicin)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Out of 22 participants enrolled, only 21 participants were randomized since 1 participant withdrew from the study.

Reporting Groups
  Description
Myrin 2 First, Then Rimactane 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.
Rimactane First, Then Myrin 2 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.

Participant Flow for 3 periods

Period 1:   First Intervention Period
    Myrin 2 First, Then Rimactane     Rimactane First, Then Myrin 2  
STARTED     10     11  
COMPLETED     10     10  
NOT COMPLETED     0     1  
Protocol Violation                 0                 1  

Period 2:   Washout Period (at Least 7 Days)
    Myrin 2 First, Then Rimactane     Rimactane First, Then Myrin 2  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  

Period 3:   Second Intervention Period
    Myrin 2 First, Then Rimactane     Rimactane First, Then Myrin 2  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Participants Eligible for Analysis 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).

Baseline Measures
    Participants Eligible for Analysis  
Number of Participants  
[units: participants]
  20  
Age, Customized  
[units: participants]
 
18 to 22 years     12  
23 to 27 years     4  
28 to 32 years     2  
33 to 37 years     2  
Gender  
[units: participants]
 
Female     0  
Male     20  



  Outcome Measures
  Show All Outcome Measures

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

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

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

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

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

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

7.  Other Pre-specified:   Number of Participants With Abnormal Safety Laboratory Test Values   [ Time Frame: Screening and Follow-up (1 week post-baseline) ]

8.  Other Pre-specified:   Clinically Significant Change From Baseline Supine Blood Pressure (BP)   [ Time Frame: Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline) ]

9.  Other Pre-specified:   Clinically Significant Change From Baseline Pulse Rate   [ Time Frame: Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline) ]

10.  Other Pre-specified:   Clinically Significant Change From Baseline Oral Temperature   [ Time Frame: Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline) ]

11.  Other Pre-specified:   Clinically Significant Change From Baseline Respiratory Rate   [ Time Frame: Baseline (Day 0), Day 1 (Hour 10), and follow-up (1 week post-baseline) ]

12.  Other Pre-specified:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Baseline (Day 0), Day 1 and Follow-up (1 week post-baseline) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01311505     History of Changes
Other Study ID Numbers: B3801001
Study First Received: February 15, 2011
Results First Received: March 23, 2012
Last Updated: June 21, 2012
Health Authority: Philippines: Department of Health