- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01728740
Bioequivalence Study for Acarbose / Metformin FDC
December 18, 2012 updated by: Bayer
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
To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 110-744
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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)
|
Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose
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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
|
Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose
Metformin 500mg, oral, single dose
|
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
|
Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose
|
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
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Metformin 500mg, oral, single dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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within 4 hours after sucrose load
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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
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within 4 hours after sucrose load
|
Cmax of metformin
Time Frame: within 24 hours after dosing
|
within 24 hours after dosing
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AUC(0-tn) of metformin
Time Frame: within 24 hours after dosing
|
within 24 hours after dosing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
November 14, 2012
First Submitted That Met QC Criteria
November 14, 2012
First Posted (Estimate)
November 20, 2012
Study Record Updates
Last Update Posted (Estimate)
December 19, 2012
Last Update Submitted That Met QC Criteria
December 18, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15420
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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