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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Acarbose

Criteria

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