CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 96 enrolled
Drug / intervention
5 mg empagliflozin/850 mg metformin FDC +11 moredrug
Likely dose
5 mg empagliflozin/850 mg metformin 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/NCT02102932
NCT02102932Phase 1Completed
CompareCT.gov

Relative Bioavailability of Empagliflozin (12.5 or 5 mg)/Metformin (850 mg or 500 mg) Fixed Dose Combination Tablets Compared to Single Tablets Administered Together to Healthy Chinese Male and Female Volunteers in an Open-label, Randomised, Single-dose, Two-way Crossover Study

Boehringer Ingelheim·interventional·Posted Apr 3, 2014·Updated Sep 24, 2015

In Brief

A Phase 1 clinical trial evaluating 5 mg empagliflozin/850 mg metformin FDC, 12.5 mg empagliflozin, and 6 other interventions for Healthy. Completed, enrolled 96 participants across 1 site.

Detailed Summary

The aim of the trial is to assess the relative bioavailability of fixed dose combination tablets of Empagliflozin and metformin compared to the administration of single tablets (Empagliflozin and metformin ) in Chinese subjects. The availability of a fixed dose combination tablet is expected to significantly enhance patient's compliance with antidiabetic treatment, in particular with concern to the frequent polypharmacy in diabetic patients.

Study Details

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

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 3, 2014
Enrollment StartMay 1, 2014
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.2 years ago

Interventions

5 mg empagliflozin/850 mg metformin FDCdrug

5 mg empagliflozin/850 mg metformin FDC

12.5 mg empagliflozindrug

10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet

12.5 mg empagliflozindrug

10mg empagliflozin tablet and 2.5 mg empagliflozin tablet

850 mg metformindrug

850mg metformin tablet

5 mg empagliflozindrug

5 mg empagliflozin

5 mg empagliflozindrug

5 mg empagliflozin

850 mg metformindrug

850 mg metformin

12.5 mg empagliflozin/850 mg metformin FDCdrug

12.5 mg empagliflozin/850 mg metformin FDC

12.5 mg empagliflozin/500 mg metformin FDCdrug

12.5 mg empagliflozin/500 mg metformin FDC

5 mg empagliflozin/500 mg metformin FDCdrug

5 mg empagliflozin/500 mg metformin FDC

500 mg metformindrug

500 mg metformin

500 mg metformindrug

500 mg metformin