CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 72 enrolled
Drug / intervention
1 tablet Empagliflozin/2 tablets Metformin XR +5 moredrug
Likely dose
10 mg Empagliflozin/1000 mg Metformin XRfrom 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/NCT02106923
NCT02106923Phase 1Completed
CompareCT.gov

Relative Bioavailability of Two Newly Developed FDC Tablet Strengths (10 mg/1000 mg and 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 Apr 8, 2014·Updated Mar 9, 2017

In Brief

A Phase 1 clinical trial evaluating 1 tablet Empagliflozin/2 tablets Metformin XR, 10 mg Empagliflozin/1000 mg Metformin XR, and 2 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 combinations (FDC) tablets containing empagliflozin \& metformin XR and the single tablets of empagliflozin and metformin XR when administered singularly

Study Details

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

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 8, 2014
Enrollment StartApr 1, 2014
Primary CompletionJun 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.2 years ago

Interventions

1 tablet Empagliflozin/2 tablets Metformin XRdrug

Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets

10 mg Empagliflozin/1000 mg Metformin XRdrug

Experimental: high dose Empagliflozin/Metformin XR, FDC tablet

1 tablet 10 mg Empagliflozin/3 tablets Metformin XRdrug

Active Comparator: 1 x Empagliflozin/3 x Metformin XR tablets

2 tablets 5 mg Empagliflozin/750 Metformin XRdrug

Experimental:2 x low dose Empagliflozin/Metformin XR FDC tablets

1 tablet Empagliflozin/2 tablets Metformin XRdrug

Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets

10 mg Empagliflozin/1000 mg Metformin XRdrug

Experimental: high dose Empagliflozin/Metformin XR, FDC tablet