Conditions: Hepatitis C
Keywords: boceprevir hepatitis C bioequivalence SCH 503034
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 177
Healthy volunteers: yes

Brief summary:
This is a single-dose, randomized, cross-sectional comparison study examining the relative safety and resulting blood level profiles after administration of a new boceprevir tablet formulation versus its current capsule formulation for treatment of chronic hepatitis C. In Part 1 of the study participants will receive boceprevir tablets and capsules under fed conditions. In Part 2 of the study a new group of participants will receive boceprevir tablets and capsules under fasted conditions.

Detailed description:

Arms:
arm 1: Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition. arm 2: Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition. arm 3: Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast, and then 4 days later will take a single dose of boceprevir capsules, orally, following an overnight fast. arm 4: Participants on this study arm will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast, and then 4 days later will take a single dose of boceprevir tablets, orally, following an overnight fast.

Interventions: intervention 1: boceprevir intervention 2: boceprevir intervention 3: boceprevir intervention 4: boceprevir
Intervention descriptions: intervention 1: Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions. intervention 2: Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions. intervention 3: Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions. intervention 4: Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.

Protocol document: