Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Linagliptin/Metformin Extended Release Compared With Single Tablets
NCT02821910 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2020-03-05
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.
Conditions
- Healthy
Interventions
- DRUG
-
High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed
High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet
- DRUG
-
1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR
1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets
- DRUG
-
High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted
High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet
- DRUG
-
1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR
1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets
- DRUG
-
Low dose FDC Empagliflozin/Linagliptin/Metformin XR, fed
Low dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet
- DRUG
-
1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR
1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-07-20
- Primary Completion
- 2016-10-01
- Completion
- 2016-10-31
Countries
- Germany
Study Locations
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