Completed PHASE1 INTERVENTIONAL 2-arm NCT02028767

Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets

Bioequivalence of Empagliflozin/Metformin (12.5mg/500mg) Fixed Dose Combination Tablets Compared to Tablets Administered Together in Healthy Male and Female Volunteers Under Fed Conditions (an Open Label, Randomised, Single Dose, Two Period, Two Sequence Crossover Study)

Sponsor: Boehringer Ingelheim

Conditions Healthy

Interventions Empagliflozin 10 mg Empagliflozin 2.5 mg Empagliflozin/Metformin FDC Metformin 500 mg

Updated 5 times since 2017 Last updated: Jun 26, 2015 Started: Jan 31, 2014 Primary completion: Feb 28, 2014 Completion: Feb 28, 2014

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02028767, this PHASE1 trial focuses on Healthy and remains completed. Sponsored by Boehringer Ingelheim, it has been updated 5 times since 2014, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1
Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Jan 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Boehringer Ingelheim

Data source: Boehringer Ingelheim

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Toronto, Canada