This Study Tests Whether Taking the Medicines Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills. The Study is Done in Healthy Men and Women and Measures the Amount of Each Medicine in the Blood
NCT03259490 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2020-03-05
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
Conditions
- Healthy
Interventions
- DRUG
-
Empagliflozin/linagliptin/metformin HCl
Once daily
- DRUG
-
Empagliflozin
Once daily
- DRUG
-
Linagliptin
Once daily
- DRUG
-
Metformin HCl
Once daily
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
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
- 2017-08-31
- Primary Completion
- 2017-11-13
- Completion
- 2017-11-13
Countries
- Germany
Study Locations
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