Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)

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

metformin XR

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

DRUG

saxagliptin + metformin XR (FDC tablet)

Tablet, Oral, (saxagliptin 5 mg)(metformin XR 500 mg), once daily, Single dose

Trial Locations (1)

Ppd Development, Lp, Austin