CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
C: BI 10773 / metformin tablet +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/NCT01211197
NCT01211197Phase 1Completed
CompareCT.gov

Relative Bioavailability of a 12.5 mg BI 10773 / 1000 mg Metformin Fixed Dose Combination Tablet Compared With Its Monocomponents and Administered With and Without Food (an Open-label, Randomised, Single-dose, Three-way Crossover, Phase I Trial in Healthy Volunteers)

Boehringer Ingelheim·interventional·Posted Sep 29, 2010·Updated Aug 21, 2015

In Brief

A Phase 1 clinical trial evaluating C: BI 10773 / metformin tablet, B: BI 10773 tablet and metformin tablet, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 16 participants across 1 site.

Detailed Summary

The objective of the current study is to determine the relative bioavailability of a BI 10773 / metformin fixed dose combination tablet compared to single tablets of BI 10773 and metformin when administered together and to assess the effect of food on the bioavailability the fixed dose combination tablet

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 29, 2010
Enrollment StartOct 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.8 years ago

Interventions

C: BI 10773 / metformin tabletdrug

BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal

B: BI 10773 tablet and metformin tabletdrug

BI 10773 and metformin single tablets, administered together in fasted state

A: BI 10773 / metformin tabletdrug

BI 10773 / metformin fixed dose combination tablet in fasted state