Trial Condition(s):
Bioequivalence study for Acarbose / Metformin FDC
15420
Not Available
Not Available
To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).
- 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
- 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
Locations | Status | |
---|---|---|
Locations Seoul National University Hospital Seoul, South Korea, 110-744 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
4