Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

August 31, 2009

Study Completion Date

August 31, 2009

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Co-administration of Saxagliptin and Metformin IR, Fasted

Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions

DRUG

Saxagliptin/Metformin, Fasting

Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions

DRUG

Co-administration of Saxagliptin and Metformin IR, Fed

Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions

DRUG

Saxagliptin/Metformin, Fed

Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions

Trial Locations (1)

68502

Mds Pharma Services, Lincoln

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY