Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 28
Healthy volunteers: yes

Brief summary:
To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state

Detailed description:

Arms:
arm 1: 500 mg metformin (Diabex): Single oral dose of 500 mg metformin (Diabex) tablet administered in the fed condition arm 2: 500 mg metformin (Glucophage™): Single oral dose of 500 mg metformin (Glucophage™) tablet administered in the fed condition arm 3: 1000 mg metformin (Diabex): Single oral dose of 1000 mg metformin (Diabex) tablet administered in the fed condition arm 4: 1000 mg metformin (Glucophage™): A Single oral dose of 1000 mg metformin (Glucophage™) tablet administered in the fed condition

Interventions: intervention 1: metformin (Diabex) intervention 2: metformin (Glucophage™) intervention 3: metformin (Glucophage™) intervention 4: metformin (Diabex)
Intervention descriptions: intervention 1: Tablets, Oral, 500 mg, Once daily, single dose intervention 2: Tablets, Oral, 500 mg, Once Daily, single dose intervention 3: Tablets, Oral, 1000 mg, Once daily, single dose intervention 4: Tablets, Oral, 1000 mg, Once daily, single dose

Protocol document: