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

Bayer

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Acarbose (Glucobay, BAYG5421); Drug: Acarbose (Glucobay ODT, BAYG5421)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01388153

2011-000904-17 (EudraCT Number)

15624

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 design

33 participants in 3 patient groups

Arm 1

Experimental group

Treatment:

Drug: Acarbose (Glucobay ODT, BAYG5421)

Drug: Acarbose (Glucobay ODT, BAYG5421)

Arm 2

Experimental group

Treatment:

Drug: Acarbose (Glucobay ODT, BAYG5421)

Drug: Acarbose (Glucobay ODT, BAYG5421)

Arm 3

Active Comparator group

Treatment:

Drug: Acarbose (Glucobay, BAYG5421)