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
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
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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