Conditions: Healthy Volunteers
Keywords: Bioequivalence RIN 150 Healthy volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 28
Healthy volunteers: yes

Brief summary:
This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.

Detailed description:

Arms:
arm 1: RIN 150 contains 150 rifampicin and 75 mg isoniazid arm 2: Individual references of rifampicin and isoniazid

Interventions: intervention 1: RIN 150 intervention 2: reference drugs
Intervention descriptions: intervention 1: Each subject will receive a single oral dose of 4 fixed dose combination tablets (RIN 150) each contains 150 rifampicin and 75 mg isoniazid. intervention 2: Each subject will receive a single oral dose of 4 x 150 mg rifampicin capsules and 3 x 100 mg isoniazid capsules.

Protocol document: