Overview

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