CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
metformin +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/NCT02266472
NCT02266472Phase 1Completed
CompareCT.gov

Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release (10 mg/1000 mg) Compared With the Free Combination of Empagliflozin and Metformin Extended Release Tablets in Healthy Subjects Following a High-fat, High-caloric Meal (an Open-label, Randomised, Single Dose, Crossover Trial)

Boehringer Ingelheim·interventional·Posted Oct 17, 2014·Updated Mar 9, 2017

In Brief

A Phase 1 clinical trial evaluating metformin, empagliflozin/metformin, and 1 other intervention for Healthy. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this trial is to investigate bioequivalence of a newly developed fixed dose combination (FDC) tablet containing empagliflozin and metformin extended release compared to the free combination of empagliflozin and metformin extended release under fed conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
CollaboratorsEli Lilly and Company

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 17, 2014
Enrollment StartNov 1, 2014
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.7 years ago

Interventions

metformindrug

single dose of metformin given as tablets

empagliflozin/metformindrug

Single dose empagliflozin/metformin given as fixed-dose combination tablet

empagliflozindrug

single dose of empagliflozin given as tablet