NCT01365091View on ClinicalTrials.gov

Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil

PHASE1CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

November 30, 2011

Study Completion Date

November 30, 2011

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Saxagliptin/metformin fixed-dose combination (FDC)

Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day

DRUG

Saxagliptin

Tablet, oral, 5 mg, once on Day 1 only, 1 day

DRUG

Metformin extended-release (XR)

Tablet, oral, 500 mg, once on Day 1 only, 1 day

DRUG

Saxagliptin/Metformin FDC

Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day

DRUG

Metformin

Tablet, oral, 1000 mg, once on Day 1 only, 1 day

Trial Locations (1)

13073

Local Institution, Campinas

Sponsors

Lead Sponsor

AstraZeneca
All Listed Sponsors
lead

AstraZeneca

INDUSTRY