At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Myrin© 2 (Rifampicin + Isoniazid) and Rimactane® (Rifampicin) for Tuberculosis. Completed, enrolled 21 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Two (2) fixed-dose combination tablets each containing Rifampicin 150 mg and Isoniazid 75 mg
One (1) capsule of Rifampicin 300 mg