Conditions: Diabetes Mellitus, Type 2
Keywords: Metformin Bioequivalence
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 25
Healthy volunteers: yes

Brief summary:
This is an open-label, single-center, randomized, 2-way crossover study to evaluate the bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference product administered as two 500 mg tablets, under fasting conditions, in 24 healthy adult subjects. Each subject will receive two treatments (Treatment A and Treatment B). In Period 1, subjects will be dosed with either one OXEMET™ 1000 mg tablet (Treatment A, Test) or two 500 mg tablets of reference product (GLAFORNIL™ 500 mg) (Treatment B, Reference). Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.

Detailed description:

Arms:
arm 1: Generic undergoing bioequivalence study against reference arm 2: Reference drug for bioequivalence study

Interventions: intervention 1: Metformin
Intervention descriptions: intervention 1: Oral antidiabetic agent

Protocol document: