A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components

PHASE1CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

June 30, 2014

Study Completion Date

June 30, 2014

Conditions
Healthy Volunteers
Interventions
DRUG

Canagliflozin, 300 mg

Each tablet contains canagliflozin (CANA) of 300 mg to be taken orally (by mouth).

DRUG

Metformin XR, 500 mg

Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth).

DRUG

CANA/MET XR FDC, Formulation 1, 150 mg/1,000 mg

Each tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 1, in release-controlling polymers to obtain the XR granulation, to be taken orally.

DRUG

CANA/MET XR FDC, Formulation 2, 150 mg/1,000 mg

Each tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 2, in release-controlling polymers to obtain the XR granulation, to be taken orally.

Trial Locations (1)

Unknown

Tempe

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02073227 - A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components | Biotech Hunter | Biotech Hunter