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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Acarbose (Glucobay ODT, BAYG5421); Drug: Acarbose (Glucobay, BAYG5421)

• Registration Number: NCT01388153
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-07
• Study First Submitted: 2011-07-04
• Study First Submitted QC: 2011-07-04
• Study First Posted: 2011-07-06
• Study Completion: 2011-08
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-27
• Last Update Posted: 2013-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 33

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Acarbose (Glucobay ODT, BAYG5421)	-
Arm 2	Acarbose (Glucobay ODT, BAYG5421)	-
Arm 3	Acarbose (Glucobay, BAYG5421)	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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