Bioequivalence Study for Acarbose / Metformin FDC

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Acarbose; Metformin

Criteria

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