Diabetes Mellitus, Type 2
Conditions
Keywords
Bioequivalence, Acarbose, ODT
Brief summary
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.
Interventions
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of postprandial maximum concentration (Cmax) of blood glucose following sucrose load with Glucobay (Day 1) and without Glucobay (Day 0) | within 4 hours after sucrose load |
| Ratio of postprandial Area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose following sucrose load with Glucobay (Day 1) and without Glucobay (Day 0) | within 4 hours after sucrose load |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in postprandial maximum concentration (Cmax) of blood glucose and serum insulin following sucrose load with acarbose (day 1) and without acarbose (day 0) | within 4 hours after sucrose load | — |
| Difference in postprandial area under curve from 0 to 4 hours (AUC(0-4)) of blood glucose and serum insulin following sucrose load with acarbose (day 1) and without acarbose (day 0) | within 4 hours after sucrose load | — |
| Safety parameters | Assessed in pre study treatment, study treatment, and follow-up visits | Adverse events (AEs), clinical chemistry, hematology, urinalysis, physical examination, systolic and diastolic blood pressure, pulse rate, electrocardiogram (ECG) |
Countries
Germany
Outcome results
None listed