CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed +5 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/NCT02821910
NCT02821910Phase 1Completed
CompareCT.gov

Relative Bioavailability of Two FDC Tablet Strengths of Empagliflozin/Linagliptin/Metformin Extended Release Compared to the Free Combination of Empagliflozin, Linagliptin and Metformin Extended Release 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 Jul 4, 2016·Updated Mar 5, 2020

In Brief

A Phase 1 clinical trial evaluating High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed, 1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR, and 2 other interventions for Healthy. Completed, enrolled 50 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, linagliptin \& metformin extended release (XR) and the single tablets of empagliflozin, linagliptin and metformin XR administered simultaneously.

Study Details

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

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 4, 2016
Enrollment StartJul 20, 2016
Primary CompletionOct 1, 2016
Study CompletionOct 31, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.0 years ago

Interventions

High dose FDC Empagliflozin/Linagliptin/Metformin XR, feddrug

High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet

1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XRdrug

1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets

High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasteddrug

High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet

1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XRdrug

1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets

Low dose FDC Empagliflozin/Linagliptin/Metformin XR, feddrug

Low dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet

1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XRdrug

1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets