Trial Condition(s):

Diabetes Mellitus, Type 2

A 3-fold crossover bioequivalence study between Glucobay ODT (Orally Disintegrating Tablet) 100 mg and Glucobay standard tablet 100 mg

Bayer Identifier:

16025

ClinicalTrials.gov Identifier:

NCT01554631

EudraCT Number:

2012-000245-12

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
34
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