Overview
A Study to Assess the Bioequivalence of 2 Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2
Status:
Completed
Completed
Trial end date:
2011-11-01
2011-11-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Treatments:
Canagliflozin
Metformin
Criteria
Inclusion Criteria:- Body mass index (BMI) between 18.5 and 30 kg/m² (inclusive) and a body weight of not less
than 50 kg
Exclusion Criteria:
- 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