A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

April 30, 2013

Study Completion Date

April 30, 2013

Conditions
Type 2 Diabetes Mellitus(T2DM)
Interventions
DRUG

Saxagliptin 5 mg

Saxagliptin oral tablet 5mg, single dose

DRUG

Metformin XR 500 mg

Metformin XR oral tablet 500 mg, single dose

DRUG

Mertformin XR 2 x 500 mg

Metformin XR oral tablet 2 x 500 mg, single dose

DRUG

Komboglyze XR 5/500 mg

oral FDC tablet (saxagliptin 5 mg and metformin 500 mg), single dose

DRUG

Komboglyze XR 5/1000 mg

oral FDC tablet (saxagliptin 5 mg and metformin 1000 mg), single dose

Trial Locations (1)

Unknown

Research Site, Beijing

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

AstraZeneca

INDUSTRY