Comparative study on the bioavailability and bioequivalence of rifapentine capsules in humans.

ABSTRACT:

Introduction

: Rifapentine, a potent semi-synthetic member of the rifamycin class, is approved for the treatment of tuberculosis due to its effective bactericidal properties. It is essential to assess the bioequivalence and bioavailability of different rifapentine formulations to ensure consistent clinical outcomes. This study compares the pharmacokinetic profiles of test and reference rifapentine capsules in healthy male volunteers.

Methods

In this single-dose, randomized, crossover study, 19 healthy male volunteers aged 18-40 received 0.6 g of either the test or reference rifapentine capsules. The reference is an NMPA-approved product, while the test is a modified version intended to match it in safety and efficacy; both contain the same active ingredient but may differ in

SUBMITTER: Qi Y 

PROVIDER: S-EPMC11782957 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature