Bioequivalence Study for Acarbose / Metformin FDC

Randomized, Non-blinded Crossover Study to Establish the Bioequivalence Between Fixed Dose Combination (FDC) and Loose Combination of Acarbose and Metformin and to Investigate the Potential for a Drug-drug Interaction Following Single Oral Dosing in Healthy Adult Male Subjects

To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).

Inclusion Criteria:

• Body Mass Index (BMI): 18 to 28 kg/m2 (inclusive)

• Results of Glycosylated Hemoglobin A1c (HbA1c) value are within the normal range (4.3-5.6%, inclusive)

• Results of the 75 g oral glucose tolerance test (OGTT) during screening show:

  • Blood glucose before OGTT <110 mg/dL.
  • Blood glucose 1 hour after glucose loading <180 mg/dL
  • Blood glucose 2 hours after glucose loading <140 mg/dL

Exclusion Criteria:

• A history of relevant diseases of internal organs (diabetes mellitus, Ileus, Ileus-like symptoms, diseases that may significantly jeopardize body systems
• Febrile illness within 1 week before drug administration
• Family history of diabetes (within the second degree of relationship)
• Known drug hypersensitivity or idiosyncrasy
• Known severe allergies, non-allergic drug reactions, or multiple drug allergies
• Habitual medication including Chinese herbal drugs
• Intake of any drugs within 2 weeks of drug administration of period 1
• Regular daily consumption of more than 1 L of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form
• Donation of more than 150 mL of blood within 4 weeks before the screening examination
• Participation in another clinical trial within 4 weeks before the screening examination