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A 3-fold Crossover Bioequivalence Study Between Glucobay ODT (Orally Disintegrating Tablet) 100 mg and Glucobay Standard Tablet 100 mg

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ClinicalTrials.gov Identifier: NCT01554631
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : June 14, 2013
Sponsor:
Information provided by:
Bayer

Study Description
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Brief Summary:
To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) 100 mg taken without or with water and the Glucobay standard tablet 100 mg taken with water.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Acarbose (Glucobay ODT, BAYG5421) Drug: Acarbose (Glucobay, BAYG5421) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Randomized, Non-blinded, 3-fold Crossover Study to Investigate the Bioequivalence Between Glucobay ODT 100 mg Taken Without and With Water and the Glucobay Standard Tablet 100 mg Following Single Oral Dosing in Healthy Male Subjects
Study Start Date : March 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1
Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT 100 mg; Day 1: oral sucrose load plus Glucobay ODT 100 mg taken without water
 Drug: Acarbose (Glucobay ODT, BAYG5421)
Experimental: Arm 2
Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT 100 mg; Day 1: oral sucrose load plus Glucobay ODT 100 mg taken with water
 Drug: Acarbose (Glucobay ODT, BAYG5421)
Active Comparator: Arm 3
Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay standard tablet 100 mg; Day 1: oral sucrose load plus Glucobay standard tablet 100 mg taken with water
 Drug: Acarbose (Glucobay, BAYG5421)


Outcome Measures
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Primary Outcome Measures :
  1. Ratio of postprandial maximum concentration (Cmax) of blood glucose following sucrose load with Glucobay (Day 1) and without Glucobay (Day 0) [ Time Frame: within 4 hours after sucrose load ]
  2. Ratio of postprandial Area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose following sucrose load with Glucobay (Day 1) and without Glucobay (Day 0) [ Time Frame: within 4 hours after sucrose load ]

Secondary Outcome Measures :
  1. Difference in postprandial maximum concentration (Cmax) of blood glucose and serum insulin following sucrose load with acarbose (day 1) and without acarbose (day 0) [ Time Frame: within 4 hours after sucrose load ]
  2. Difference in postprandial area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose and serum insulin following sucrose load with acarbose (day 1) and without acarbose (day 0) [ Time Frame: within 4 hours after sucrose load ]
  3. Safety parameters [ Time Frame: Assessed in pre study treatment, study treatment, and follow-up visits ]
    Adverse events (AEs), clinical chemistry, hematology, urinalysis, physical examination, systolic and diastolic blood pressure, pulse rate, electrocardiogram (ECG)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subject
  • Age: 18 to 45 years (inclusive) at the first screening examination / visit
  • Ethnicity: White
  • Body mass index (BMI): above/equal 18 and below/equal 28 kg / m²

Exclusion Criteria:

  • Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
  • Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor
  • Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
  • Known severe allergies, non-allergic drug reactions, or multiple drug allergies
  • Chronic intestinal disorders associated with distinct disturbances of digestion and absorption
  • States which may deteriorate as a result of increased gas formation in the intestine (e.g. Roemheld´s syndrome, major hernias, intestinal obstructions, intestinal ulcers, Crohn´s disease, ulcerative colitis, malabsorptions)
  • Fasting blood glucose level outside normal range
  • Impaired glucose tolerance in glucose tolerance test
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554631


Locations
Germany
Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

Responsible Party: Head Clinical Pharmacology, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01554631     History of Changes
Other Study ID Numbers: 16025
2012-000245-12 ( EudraCT Number )
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: June 14, 2013
Last Verified: June 2013

Keywords provided by Bayer:
Bioequivalence
Acarbose
ODT

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Acarbose
 Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs