Bioequivalence Study for Acarbose / Metformin FDC | RxWiki

Bioequivalence Study for Acarbose / Metformin FDC

Overview[ - collapse ][ - ]

Purpose	To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).
Condition	Diabetes Mellitus, Type II
Intervention	Drug: Acarbose/Metformin FDC (BAY81-9783) Drug: Acarbose (Glucobay, BAYG5421) Drug: Metformin
Phase	Phase 1
Sponsor	Bayer
Responsible Party	Bayer
ClinicalTrials.gov Identifier	NCT01728740
First Received	November 14, 2012
Last Updated	December 18, 2012
Last verified	December 2012

Tracking Information[ + expand ][ + ]

First Received Date	November 14, 2012
Last Updated Date	December 18, 2012
Start Date	September 2012
Estimated Primary Completion Date	December 2012
Current Primary Outcome Measures	Ratio of postprandial maximum concentration (Cmax) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0) [Time Frame: within 4 hours after sucrose load] [Designated as safety issue: No] Ratio of postprandial Area Under the Curve (AUC(0 4)) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0) [Time Frame: within 4 hours after sucrose load] [Designated as safety issue: No] Cmax of metformin [Time Frame: within 24 hours after dosing] [Designated as safety issue: No] AUC(0-tn) of metformin [Time Frame: within 24 hours after dosing] [Designated as safety issue: No]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Bioequivalence Study for Acarbose / Metformin FDC
Official 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
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 Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Condition	Diabetes Mellitus, Type II
Intervention	Drug: Acarbose/Metformin FDC (BAY81-9783) Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose Drug: Acarbose (Glucobay, BAYG5421) Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose Drug: Metformin Metformin 500mg, oral, single dose
Study Arm (s)	Experimental: Acarbose/Metformin FDC 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) Active Comparator: Acarbose+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 Active Comparator: Acarbose 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 Active Comparator: 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

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	40
Estimated Completion Date	December 2012
Estimated Primary Completion Date	December 2012
Eligibility Criteria	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
Gender	Male
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT01728740
Other Study ID Numbers	15420
Has Data Monitoring Committee	No
Information Provided By	Bayer
Study Sponsor	Bayer
Collaborators	Not Provided
Investigators	Study Director: Bayer Study Director Bayer
Verification Date	December 2012

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