Overview

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

Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
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 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