Trial Condition(s):

Diabetes Mellitus, Type 2

A 3-fold crossover bioequivalence study between Glucobay Orally Disintegrating Tablet (ODT) and Glucobay standard tablet

Bayer Identifier:

15624

ClinicalTrials.gov Identifier:

NCT01388153

EudraCT Number:

2011-000904-17

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
33
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Glucobay ODT (Acarbose, BAYG5421)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

CRS Clinical-Research-Services Mönchengladbach GmbH

Mönchengladbach, Germany, 41061

Status
Completed
 

Trial Design