NCT02065752View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
Healthy Volunteers
Interventions
DRUG

Canagliflozin, 100 mg

Each tablet contains canagliflozin (CANA) of 100 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, 50 mg/500 mg

Each tablet contains 50 mg of canagliflozin and 500 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, 50 mg/500 mg

Each tablet contains 50 mg of canagliflozin and 500 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

NCT02065752 - 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