Bioequivalence Study for Acarbose / Metformin FDC

Study Overview
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Brief Summary
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To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).

Official Title
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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

Conditions
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Diabetes Mellitus, Type II

Intervention / Treatment
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* Drug: Acarbose/Metformin FDC (BAY81-9783)
* Drug: Acarbose (Glucobay, BAYG5421)
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acarbose/Metformin FDC<br>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) | Drug: Acarbose/Metformin FDC (BAY81-9783)<br>* Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose<br>|
| Active Comparator: Acarbose+Metformin<br>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 | Drug: Acarbose (Glucobay, BAYG5421)<br>* Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose<br>Drug: Metformin<br>* Metformin 500mg, oral, single dose<br>|
| Active Comparator: Acarbose<br>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 | Drug: Acarbose (Glucobay, BAYG5421)<br>* Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose<br>|
| Active Comparator: Metformin<br>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 | Drug: Metformin<br>* Metformin 500mg, oral, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| AUC(0-tn) of metformin |  | within 24 hours after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FDC, Bioequivalence, Acarbose, Metformin