Clinical trial NCT01388153: A 3-fold Crossover Bioequivalence Study Between Glucobay Orally Disintegrating Tablet (ODT) and Glucobay Standard Tablet
Official title: Randomized, Non-blinded, 3-fold Crossover Study to Investigate the Bioequivalence Between Glucobay ODT Taken Without and With Water and the Glucobay Standard Tablet Following Single Oral Dosing in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Bioequivalence, acarbose, ODT
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-07-06
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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


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

Primary outcomes:
measure: Difference of postprandial maximum concentration (Cmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)
timeFrame: within 4 hours after sucrose load
measure: Difference of postprandial Area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)
timeFrame: within 4 hours after sucrose load
Secondary outcomes:
measure: Time to reach maximum drug concentration in plasma after single dose (tmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)
timeFrame: within 4 hours after sucrose load
measure: Difference of postprandial Cmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)
timeFrame: within 4 hours after sucrose load
measure: Difference of postprandial AUC(0-4) of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)
timeFrame: within 4 hours after sucrose load
measure: Tmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)
timeFrame: within 4 hours after sucrose load
Other outcomes:
Locations:
city: Mönchengladbach
country: Germany
state: Nordrhein-Westfalen
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: