Overview

A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers

Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the bioequivalence of a fixed dose combination (FDC) tablet of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Janssen Research & Development, LLC
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