Diabetes Mellitus, Type 2
Conditions
Keywords
Bioequivalence, acarbose, ODT
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
Interventions
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
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
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference of postprandial maximum concentration (Cmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2) | within 4 hours after sucrose load |
| 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) | within 4 hours after sucrose load |
Secondary
| Measure | Time frame |
|---|---|
| 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) | within 4 hours after sucrose load |
| Difference of postprandial Cmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2) | within 4 hours after sucrose load |
| Difference of postprandial AUC(0-4) of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2) | within 4 hours after sucrose load |
| Tmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2) | within 4 hours after sucrose load |
Countries
Germany
Outcome results
None listed