CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 177 enrolled
Drug / intervention
boceprevir +3 moredrug
Likely dose
boceprevir 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01181804
NCT01181804Phase 1Completed
CompareCT.gov

A Definitive Bioequivalence Study of a New Boceprevir (SCH 503034) Tablet Formulation Compared to the Current Capsule Form in Healthy Male and Female Subjects.

Merck Sharp & Dohme LLC·interventional·Posted Aug 13, 2010·Updated Apr 7, 2017

In Brief

A Phase 1 clinical trial evaluating boceprevir for Hepatitis C. Completed, enrolled 177 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 13, 2010
Enrollment StartJun 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.9 years ago

Interventions

boceprevirdrug

Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.

boceprevirdrug

Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.

boceprevirdrug

Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.

boceprevirdrug

Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.