Bioequivalence Study for Acarbose / Metformin FDC
Phase 1
Completed
- Conditions
- Diabetes Mellitus, Type II
- Interventions
- Registration Number
- NCT01728740
- Lead Sponsor
- Bayer
- Brief Summary
To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Acarbose/Metformin FDC Acarbose/Metformin FDC (BAY81-9783) Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Acarbose/Metformin FDC; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose/Metformin FDC (containing 50 mg Acarbose and 500 mg Metformin) Acarbose+Metformin Acarbose (Glucobay, BAYG5421) Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without loose combination of Acarbose and Metformin; Day 1: oral sucrose load plus single dose of 1 tablet each of a loose combination of Acarbose 50 mg and Metformin 500 mg Acarbose Acarbose (Glucobay, BAYG5421) Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose 50 mg Acarbose+Metformin Metformin Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without loose combination of Acarbose and Metformin; Day 1: oral sucrose load plus single dose of 1 tablet each of a loose combination of Acarbose 50 mg and Metformin 500 mg Metformin Metformin Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Metformin 500 mg
- Primary Outcome Measures
Name Time Method AUC(0-tn) of metformin within 24 hours after dosing Ratio of postprandial Area Under the Curve (AUC(0 4)) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0) within 4 hours after sucrose load Cmax of metformin within 24 hours after dosing Ratio of postprandial maximum concentration (Cmax) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0) within 4 hours after sucrose load
- Secondary Outcome Measures
Name Time Method