Overview

Bioequivalence Study of Metformin Component of Fixed Dose Combination (FDC) Immediate Release (IR) Tablet of Canagliflozin and Metformin Compared to Metformin IR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants

Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the bioequivalence of metformin component of the canagliflozin and metformin immediate release (IR) fixed dose combination (FDC) tablet compared with the metformin IR tablet co-administered with canagliflozin in healthy fed and fasted participants.
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 kilogram per square meter (kg/m^2)
(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