Status:
COMPLETED
Bioequivalence Study of Metformin Component of Fixed Dose Combination (FDC) Immediate Release (IR) Tablet of Canagliflozin and Metformin Compared to Metformin IR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Bioequivalence
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the bioequivalence of metformin component of the canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet compared with the metfo...
Detailed Description
This is a randomized (study medication assigned to participants by chance), open-label (identity of study drug will be known to volunteer and study staff), single-center, single-dose, 4-treatment, 4-w...
Eligibility Criteria
Inclusion
- Body mass index (BMI) between 18.5 and 30 kilogram per square meter (kg/m\^2) (inclusive) and a body weight of not less than 50 kg
Exclusion
- History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT02221180
Start Date
August 1 2014
End Date
November 1 2014
Last Update
November 25 2014
Active Locations (1)
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1
Lincoln, Nebraska, United States