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

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

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Locations

Germany

Mönchengladbach, Nordrhein-Westfalen, Germany, 41061

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• 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
• Last Update Posted: June 14, 2013
• Last Verified: June 2013

Keywords provided by Bayer:

Bioequivalence; Acarbose; ODT

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Diabetes Mellitus; 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