Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Extended Release (XR) Compared With Single Tablets



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:5/5/2014
Start Date:April 2014
End Date:July 2014
Contact:Boehringer Ingelheim Call Center
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

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Trial Summary
Trial Overview
Inclusion Criteria

Relative Bioavailability of Two Newly Developed FDC Tablet Strengths (10 mg/1000 mg and 5mg/750mg) of Empagliflozin/Metformin Extended Release Compared With the Free Combination of Empagliflozin and Metformin Extended Release in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Study)

The purpose of this trial is to demonstrate the relative bioavailability of 2 newly
developed fixed dose combinations (FDC) tablets containing empagliflozin & metformin XR and
the single tablets of empagliflozin and metformin XR when administered singularly


Inclusion criteria:

1. Healthy males or females

2. Age 18-50 years (incl.)

3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)

4. Subjects must be able to understand and comply with study requirements

Exclusion criteria:

Any deviation from healthy condition
We found this trial at
1
site
Boehringer Ingelheim Investigational Site
Austin, Texas
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Austin, TX
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