Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 27
Healthy volunteers: yes

Brief summary:
To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.

Detailed description:

Arms:
arm 1: Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fasted state arm 2: Single oral dose of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet administered in the fasted state arm 3: Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fed state arm 4: Single oral dose of saxagliptin, 2.5 mg/metformin, 500 mg, FDC tablet administered in the fed state

Interventions: intervention 1: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state) intervention 2: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state) intervention 3: Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state) intervention 4: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)
Intervention descriptions: intervention 1: Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week intervention 2: Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week intervention 3: Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week intervention 4: Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week

Protocol document: