A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin Extended Release Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

August 31, 2016

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 2016

Conditions
Healthy
Interventions
DRUG

Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]

Participants will receive 1 XR FDC tablet containing canagliflozin 150 mg and metformin 1000 mg orally under fed (Treatment B)or fasted condition (Treatment D) in a given treatment period as per treatment sequence.

DRUG

Canagliflozin

Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablets) under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.

DRUG

Canagliflozin

Participants will receive canagliflozin 100 mg oral tablet under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.

DRUG

Metformin Extended Release (XR)

Participants will receive metformin XR 500 mg tablet orally under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.

Trial Locations (1)

Unknown

Tempe

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02851212 - A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin Extended Release Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants | Biotech Hunter | Biotech Hunter