To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose
combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).
Drug: Acarbose/Metformin FDC (BAY81-9783)
Drug: Acarbose (Glucobay, BAYG5421)
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Locations near you
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Full eligibility criteria for NCT01728740
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
Body Mass Index (BMI): 18 to 28 kg/m2 (inclusive)
Results of Glycosylated Hemoglobin A1c (HbA1c) value are within the normal range
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
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
All locations for NCT01728740
Korea, Republic of (1)
Seoul, Korea, Republic of, 110-744
View full eligibility
Tris trial is registered with FDA with number: NCT01728740. The sponsor of the trial is Bayer and it is looking for 40 volunteers for the current phase.
Official trial title: 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
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