CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
BI 10773 25 mg +3 moredrug
Likely dose
BI 10773 25 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/NCT01111331
NCT01111331Phase 1Completed
CompareCT.gov

Relative Bioavailability of Both BI 10773 and Warfarin and Pharmacodynamics of Warfarin After Co-administration Compared to Multiple Oral Doses of BI 10773 (25 mg Once Daily) and a Single Oral Dose of Warfarin (25 mg) Alone in Healthy Male Volunteers (an Open-label, Crossover, Clinical Phase I Study)

Boehringer Ingelheim·interventional·Posted Apr 27, 2010·Updated Jul 23, 2014

In Brief

A Phase 1 clinical trial evaluating BI 10773 25 mg, Warfarin 25 mg, and 1 other intervention for Healthy. Completed, enrolled 18 participants across 1 site.

Detailed Summary

The objective of the current study is to investigate the bioavailability of BI 10773 and of warfarin after concomitant multiple oral administration of BI 10773 and a single oral dose of warfarin in comparison to BI 10773 and warfarin given alone, and to investigate the pharmacodynamics of a single oral dose of warfarin with and without concomitant multiple oral administration of BI 10773.

Study Details

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

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 27, 2010
Enrollment StartMay 1, 2010
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.2 years ago

Interventions

BI 10773 25 mgdrug

25 mg BI 10773 qd for 5 days

Warfarin 25 mgdrug

25 mg Warfarin single dose

BI 10773 25 mgdrug

25 mg BI 10773 qd for 12 days

Warfarindrug

25 mg warfarin single dose with and without 50 mg BI 10773