Status:
COMPLETED
A Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the bioequivalence of a fixed dose combination tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of can...
Detailed Description
This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence of canagliflozin and metformin when administered orally (b...
Eligibility Criteria
Inclusion
- Body mass index (BMI) between 18.5 and 30 kg/m² 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 :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01463774
Start Date
September 1 2011
End Date
December 1 2011
Last Update
November 21 2012
Active Locations (1)
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1
Lincoln, Nebraska, United States