Conditions: Tuberculosis
Keywords: bioequivalence; rifampicin
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 21
Healthy volunteers: yes

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.

Detailed description:

Arms:
arm 1: Test arm 2: Reference

Interventions: intervention 1: Myrin© 2 (Rifampicin + Isoniazid) intervention 2: Rimactane® (Rifampicin)
Intervention descriptions: intervention 1: Two (2) fixed-dose combination tablets each containing Rifampicin 150 mg and Isoniazid 75 mg intervention 2: One (1) capsule of Rifampicin 300 mg

Protocol document: