CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 25 enrolled
Drug / intervention
Empagliflozin +3 moredrug
Likely dose
Empagliflozin 12.5 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/NCT02577315
NCT02577315Phase 1Completed

An Open-label, Randomised, Single-dose, Two-way Crossover Study in Healthy Male and Female Subjects to Evaluate the Bioequivalence of Two Fixed Dose Combination Tablets of Empagliflozin 12.5 mg and Metformin 500 mg Compared With the Free Combination of Empagliflozin 25 mg and Metformin 1000 mg Tablets Under Fed Conditions

Boehringer Ingelheim·interventional·Posted Oct 16, 2015·Updated Nov 30, 2016

In Brief

A Phase 1 clinical trial evaluating Empagliflozin and Metformin for Healthy. Completed, enrolled 25 participants across 1 site.

Detailed Summary

Bioequivalence of two 12.5 mg empagliflozin/500 mg metformin fixed dose combination tablets compared to the free combination of empagliflozin 25 mg and metformin 1000 mg in healthy male and female volunteers under fed conditions

Study Details

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

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 16, 2015
Enrollment StartSep 1, 2015
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 10.7 years ago

Interventions

Empagliflozindrug

Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin

Metformindrug

Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin

Empagliflozindrug

Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin

Metformindrug

Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin