Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)

Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week

DRUG

Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state)

Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week

DRUG

Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)

Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week

DRUG

Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)

Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week

Trial Locations (1)

78744

Ppd Development, Lp, Austin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY