CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Empagliflozin/linagliptin/metformin HCl +3 moredrug
Likely dose
Not stated in 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/NCT03259490
NCT03259490Phase 1Completed
CompareCT.gov

Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Linagliptin/Metformin Extended Release Compared to the Free Combination of Empagliflozin, Linagliptin, and Metformin Extended Release Tablets Following Oral Administration in Healthy Male and Female Subjects (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Study)

Boehringer Ingelheim·interventional·Posted Aug 23, 2017·Updated Mar 5, 2020

In Brief

A Phase 1 clinical trial evaluating Empagliflozin/linagliptin/metformin HCl, Empagliflozin, and 2 other interventions for Healthy. Completed, enrolled 30 participants across 1 site.

Detailed Summary

To establish the bioequivalence of one fixed dose combination (FDC) tablet of empagliflozin/linagliptin/metformin extended release (XR) versus the free combination of empagliflozin tablet, linagliptin tablet, and metformin XR tablets administered as a single dose under fed conditions

Study Details

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

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedAug 23, 2017
Enrollment StartAug 31, 2017
Primary CompletionNov 13, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.9 years ago

Interventions

Empagliflozin/linagliptin/metformin HCldrug

Once daily

Empagliflozindrug

Once daily

Linagliptindrug

Once daily

Metformin HCldrug

Once daily