CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 56 enrolled
Drug / intervention
BI 201335 (Reference) +7 moredrug
Likely dose
Not stated in 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/NCT01764945
NCT01764945Phase 1Completed
CompareCT.gov

Relative Bioavailability of BI 201335 (Capsule) Compared to Three Different Oral Solutions of BI 201335 Following Oral Administration in Healthy Male and Female Volunteers (an Open-label, Randomised, Single-dose, Four-way Crossover Study)

Boehringer Ingelheim·interventional·Posted Jan 10, 2013·Updated Jul 31, 2015

In Brief

A Phase 1 clinical trial evaluating BI 201335 (Reference) and BI 201335 (Test) for Healthy. Completed, enrolled 56 participants across 1 site.

Detailed Summary

The objective of the current study is to investigate the relative bioavailability of two different doses of BI 201335, administered as soft gelatine capsule in comparison to the equivalent doses of three different oral solution per dose of BI 201335.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 10, 2013
Enrollment StartJan 1, 2013
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.5 years ago

Interventions

BI 201335 (Reference)drug

soft gelatine capsule, oral administration

BI 201335 (Test)drug

oral solution 3

BI 201335 (Test)drug

oral solution 3

BI 201335 (Test)drug

oral solution 2

BI 201335 (Reference)drug

soft gelatine capsule, oral administration

BI 201335 (Test)drug

oral solution 1

BI 201335 (Test)drug

oral solution 1

BI 201335 (Test)drug

oral solution 2