A 3-fold Crossover Bioequivalence Study Between Glucobay ODT (Orally Disintegrating Tablet) 100 mg and Glucobay Standard Tablet 100 mg

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

NCT01554631

2012-000245-12 (EudraCT Number)

16025

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 design

34 participants in 3 patient groups

Arm 1

Experimental group

Description:

Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT 100 mg; Day 1: oral sucrose load plus Glucobay ODT 100 mg taken without water

Treatment:

Drug: Acarbose (Glucobay ODT, BAYG5421)

Arm 2

Experimental group

Description:

Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT 100 mg; Day 1: oral sucrose load plus Glucobay ODT 100 mg taken with water

Treatment:

Drug: Acarbose (Glucobay ODT, BAYG5421)

Arm 3

Active Comparator group

Description:

Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay standard tablet 100 mg; Day 1: oral sucrose load plus Glucobay standard tablet 100 mg taken with water

Treatment:

Drug: Acarbose (Glucobay, BAYG5421)