CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 48 enrolled
Drug / intervention
Empagliflozin +8 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/NCT01811953
NCT01811953Phase 1Completed

Bioequivalence of Empagliflozin/Metformin Fixed Dose Combination Tablets Compared to Single Tablets Administered Together in Healthy Male and Female Volunteers Under Fed and Fasted Conditions (an Open-label, Randomised, Single-dose, Crossover Study)

Boehringer Ingelheim·interventional·Posted Mar 15, 2013·Updated Jul 27, 2015

In Brief

A Phase 1 clinical trial evaluating Empagliflozin, Metformin, and 1 other intervention for Healthy. Completed, enrolled 48 participants across 1 site.

Detailed Summary

Bioequivalence of an empagliflozin/metformin (FDC) tablet compared with single tablets of two strength of empagliflozin and metformin (Part I) under fasted and under fed conditions and bioequivalence of empagliflozin/metformin (FDC) tablet compared with single tablets empagliflozin and metformin under fed conditions (Part II).

Study Details

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

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2013
Enrollment StartMar 1, 2013
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.3 years ago

Interventions

Empagliflozindrug

medium dose oral administration

Metformindrug

oral administration

Empagliflozindrug

low dose of Empagliflozin oral administration

Empagliflozin/Metformindrug

low dose of Empagliflozin

Metformindrug

oral administration

Empagliflozin/Metformindrug

medium dose of Empagliflozin oral administration

Empagliflozindrug

medium dose oral administration

Metformindrug

oral administration

Empagliflozin/Metformindrug

medium dose of Empagliflozin oral administration