NCT02637037View on ClinicalTrials.gov

A Study to Assess the Bioequivalence of Dapagliflozin/Metformin XR Fixed-dose Combination Tablets in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

December 21, 2015

Primary Completion Date

April 7, 2016

Study Completion Date

April 7, 2016

Conditions
BioequivalenceFixed Dose Combination TabletsHealthy Male and Female Subjects
Interventions
DRUG

dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon)

single fixed-combination dose tablets

DRUG

dapagliflozin/metformin XR 5/500 mg reference drug (Humacao)

single fixed-dose combination tablets

DRUG

dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)

single fixed-dose combination tablets

DRUG

dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)

single fixed-dose combination tablets

Trial Locations (1)

21225

Research Site, Baltimore

Sponsors

Lead Sponsor

AstraZeneca
All Listed Sponsors
lead

AstraZeneca

INDUSTRY