Status:
COMPLETED
Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin \[Test 1\] and low dose empagliflo...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy male and female subjects
- Subjects must be able to understand and comply with study requirements
- Age 18 to 50 years
- Body mass index (BMI) 18.5 to 29.9 kg/m2
- Exclusion criteria:
- 1\. Any relevant deviation from healthy conditions
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01844531
Start Date
April 1 2013
End Date
November 1 2013
Last Update
July 27 2015
Active Locations (1)
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1
1276.6.1 Boehringer Ingelheim Investigational Site
Biberach, Germany