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

NCT ID: NCT01388153

Last Updated: 2013-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-08-31

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Acarbose (Glucobay ODT, BAYG5421)

Intervention Type: DRUG

Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken without water

Arm 2

Group Type: EXPERIMENTAL

Acarbose (Glucobay ODT, BAYG5421)

Intervention Type: DRUG

Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken with water

Arm 3

Group Type: ACTIVE_COMPARATOR

Acarbose (Glucobay, BAYG5421)

Intervention Type: DRUG

Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay standard tablet; Day 2: oral sucrose load plus Glucobay standard tablet taken with water

Interventions

Acarbose (Glucobay ODT, BAYG5421)

Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken without water

Intervention Type: DRUG

Acarbose (Glucobay ODT, BAYG5421)

Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken with water

Intervention Type: DRUG

Acarbose (Glucobay, BAYG5421)

Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay standard tablet; Day 2: oral sucrose load plus Glucobay standard tablet taken with water

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Bayer Healthcare AG

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Mönchengladbach, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

2011-000904-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

15624

Identifier Type: -

Identifier Source: org_study_id