Conditions: Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 30
Healthy volunteers: yes

Brief summary:
The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana) relative to a coadministered 5 mg Onglyza tablet (saxagliptin, manufactured in Mt Vernon, Indiana) and two 500 mg Glucophage XR tablets (metformin XR, manufactured in Evansville, Indiana) in the fed state in healthy subjects.

Detailed description:
This study is designed to evaluate if the FDC tablet of 5 mg saxagliptin/1000 mg metformin extended release (manufactured in Mt Vernon, Indiana) is bioequivalent to the coadministered 5 mg saxagliptin tablet plus 2 x 500 mg Glucophage XR tablets (manufactured in Evansville, Indiana)

Arms:
arm 1: None arm 2: under fed state, single dose arm 3: under fed state, 4 days

Interventions: intervention 1: saxagliptin intervention 2: Glucophage XR intervention 3: saxagliptin + metformin XR (FDC tablet)
Intervention descriptions: intervention 1: Tablets, Oral, 5 mg, once daily, Single dose intervention 2: Tablets, Oral, 500 mg, once daily, Single dose intervention 3: Tablet, Oral, (saxagliptin 5 mg)(metformin XR 1000 mg), once daily, 4 days

Protocol document: