At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 enrolled
Drug / intervention
BI 201335 NA 120 mg capsule +3 moredrug
Likely dose
BI 201335 NA 120 mg capsulefrom 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.
Assessment of Bioequivalence Between Two Different Formulations of BI 201335 NA Soft Gelatine Capsules in Healthy Male Volunteers. (an Open-label, Randomised, Single-dose, Four-period Replicated Crossover Study)
In Brief
A Phase 1 clinical trial evaluating BI 201335 NA 120 mg capsule and BI 201335 NA 40 mg capsule for Hepatitis C. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The objective is to investigate the bioequivalence of 2 dose strengths of 40 mg and 120 mg BI 201335 NA soft gelatine capsules.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedOct 2012
Primary CompletionJan 2013
TodayJul 2026
First PostedOct 12, 2012
Enrollment StartOct 1, 2012
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.7 years ago
Interventions
BI 201335 NA 120 mg capsuledrug
1capsule of BI 201335 NA 120 mg capsule
BI 201335 NA 120 mg capsuledrug
1 capsule of BI 201335 NA 120 mg capsule
BI 201335 NA 40 mg capsuledrug
3 capsules of BI 201335 NA 40 mg capsule
BI 201335 NA 40 mg capsuledrug
3 capsules of BI 201335 NA 40 mg capsule