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

Randomized, Non-blinded, 3-fold Crossover Study to Investigate the Bioequivalence Between Glucobay ODT Taken Without and With Water and the Glucobay Standard Tablet Following Single Oral Dosing in Healthy Male Subjects

To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) taken without or with water and the Glucobay standard tablet taken with water

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Acarbose (Glucobay ODT, BAYG5421); Drug: Acarbose (Glucobay ODT, BAYG5421); Drug: Acarbose (Glucobay, BAYG5421)

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Mönchengladbach, Nordrhein-Westfalen, Germany, 41061

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• The informed consent must be signed before any study specific tests or procedures are done
• 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
• Confirmation of the subject's health insurance coverage prior to the first screening examination / visit
• Ability to understand and follow study-related instructions

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: Acarbose (Glucobay ODT, BAYG5421); Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken without water; Drug: Acarbose (Glucobay ODT, BAYG5421); Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken with water
Experimental: Arm 2	Drug: Acarbose (Glucobay ODT, BAYG5421); Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken without water; Drug: Acarbose (Glucobay ODT, BAYG5421); Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken with water
Active Comparator: Arm 3	Drug: Acarbose (Glucobay, BAYG5421); Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay standard tablet; Day 2: oral sucrose load plus Glucobay standard tablet taken with water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference of postprandial maximum concentration (Cmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)	within 4 hours after sucrose load
Difference of postprandial Area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)	within 4 hours after sucrose load

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to reach maximum drug concentration in plasma after single dose (tmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)	within 4 hours after sucrose load
Difference of postprandial Cmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)	within 4 hours after sucrose load
Difference of postprandial AUC(0-4) of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)	within 4 hours after sucrose load
Tmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)	within 4 hours after sucrose load

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: July 4, 2011
• First Submitted That Met QC Criteria: July 4, 2011
• First Posted (Estimate): July 6, 2011

Study Record Updates

• Last Update Posted (Estimate): August 28, 2013
• Last Update Submitted That Met QC Criteria: August 27, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Bioequivalence, acarbose, ODT
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Acarbose
• Other Study ID Numbers: 15624; 2011-000904-17 (EudraCT Number)