CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 72 enrolled
Drug / intervention
Empagliflozin/Metformin XR, FDC +5 moredrug
Likely dose
25 mg Empagliflozin/1000 mg Metformin XR, FDCfrom 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/NCT01975220
NCT01975220Phase 1Completed
CompareCT.gov

Relative Bioavailability of Two Newly Developed FDC Tablet Strengths (25mg/1000mg and 12.5mg/750mg) of Empagliflozin/Metformin Extended Release Compared With the Free Combination of Empagliflozin and Metformin Extended Release in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Study)

Boehringer Ingelheim·interventional·Posted Nov 4, 2013·Updated Mar 8, 2017

In Brief

A Phase 1 clinical trial evaluating Empagliflozin/Metformin XR, FDC, Empagliflozin/Metformin XR FDC, and 3 other interventions for Healthy. Completed, enrolled 72 participants across 1 site.

Detailed Summary

The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing empagliflozin \& metformin and the single tablets of empagliflozin and metformin when administered singularly.

Study Details

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

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 4, 2013
Enrollment StartOct 1, 2013
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.7 years ago

Interventions

Empagliflozin/Metformin XR, FDCdrug

Experimental: high dose empagliflozin/metformin XR, FDC tablet

Empagliflozin/Metformin XR FDCdrug

Experimental: low dose empagliflozin/metformin XR, FDC tablet

25 mg Empagliflozin/1000 mg Metformin XR, FDCdrug

Experimental, high dose Empagliflozin/Metformin XR,FDC Tablet

1 tablet Empagliflozin/2 tablets Metformin XRdrug

Active Comparator: 1x empagliflozin/2x metformin XR tablets

1 tablet Empagliflozin/3 tablets Metformin XRdrug

Active Comparator: 1x empagliflozin/3x metformin XR tablets

1 tablet Empagliflozin/2 tablets Metformin XRdrug

Active Comparator: 1x empagliflozin/2x metformin XR tablets