A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Fed Subjects
A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 FDC Tablets of Canagliflozin and Metformin IR (50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin IR Tablets (2 x 1,000 mg) in Healthy Fed Subjects
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.
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 IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as fixed-dose combination (FDC) tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a washout period of approximately 15 days between treatments.
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: