Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR

PHASE1CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions

Diabetes Mellitus

Interventions

DRUG

saxagliptin

Tablets, Oral, 5 mg, once daily, Single dose

DRUG

Glucophage XR

Tablets, Oral, 500 mg, once daily, Single dose

DRUG

saxagliptin + metformin XR (FDC tablet)

Tablet, Oral, (saxagliptin 5 mg)(metformin XR 1000 mg), once daily, 4 days

Trial Locations (1)

PPD Development, LP, Austin