Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 24
Healthy volunteers: yes

Brief summary:
To demonstrate bioequivalence of a 2.5 mg saxagliptin/850 mg metformin fixed dose combination (FDC) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (Glucophage Marketed by Merck-Serono) tablet co-administered to healthy subjects in the fasted and fed condition.

Detailed description:

Arms:
arm 1: A single oral dose of 2.5-mg Onglyza tablet and 850-mg Glucophage (marketed by Merck Serono) tablet administered together in the fasted condition. arm 2: A single oral dose of 2.5-mg saxagliptin/850-mg metformin fixed dose combination (FDC) administered in the fasted condition. arm 3: A single oral dose of 2.5-mg Onglyza tablet and 850-mg Glucophage (marketed by Merck Serono) tablet administered together in the fed condition. arm 4: A single oral dose of 2.5-mg saxagliptin/850-mg metformin FDC administered in the fed condition.

Interventions: intervention 1: saxagliptin intervention 2: metformin intervention 3: saxagliptin + metformin (FDC tablet)
Intervention descriptions: intervention 1: Tablets, Oral, 2.5 mg, once daily, single dose intervention 2: Tablets, Oral, 850 mg, once daily, single dose intervention 3: Tablet, oral, (saxagliptin 2.5 mg) (metformin 850 mg), once daily, single dose

Protocol document: