CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
BI 207127 +2 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/NCT01535638
NCT01535638Phase 1Completed
CompareCT.gov

Relative Bioavailability of BI 207127 FF Tablets, BI 207127 FF Modified Tablets and BI 207127 TFII Tablets Administered Orally as Three Tablets (Single Dose) to Healthy Male Volunteers, an Open-label, Randomised Three-way Crossover Study

Boehringer Ingelheim·interventional·Posted Feb 20, 2012·Updated Apr 11, 2016

In Brief

A Phase 1 clinical trial evaluating BI 207127 for Healthy. Completed, enrolled 18 participants across 1 site.

Detailed Summary

The primary objective of the current study is to investigate the relative bioavailability of three trial formulations of BI 207127, the trial formulation 2 (TFII), the final formulation (FF), and a FF modified formulation. All formulations are supplied as film-coated Tablets and administered as single dose treatments of BI 207127 (3 film-coated Tablets) in healthy volunteers, with the aim to compare the bioavailability of the three formulations. All treatments will be applied fed, 30 minutes after start of the intake of a standard normal breakfast.

Study Details

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

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 20, 2012
Enrollment StartFeb 1, 2012
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.4 years ago

Interventions

BI 207127drug

Medium dose film-coated tablet

BI 207127drug

Medium dose film-coated tablet

BI 207127drug

Medium dose film-coated tablet