Trial Condition(s):
Diabetes Mellitus, Type 2
A 3-fold crossover bioequivalence study between Glucobay ODT (Orally Disintegrating Tablet) 100 mg and Glucobay standard tablet 100 mg
Bayer Identifier:
16025
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations CRS Clinical-Research-Services Mönchengladbach GmbH Mönchengladbach, Germany, 41061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Randomized, non-blinded, 3-fold crossover study to investigate the bioequivalence between Glucobay ODT 100 mg taken without and with water and the Glucobay standard tablet 100 mg following single oral dosing in healthy male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
3
Primary Outcome
- Ratio of postprandial maximum concentration (Cmax) of blood glucose following sucrose load with Glucobay (Day 1) and without Glucobay (Day 0)Timeframe: 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)Timeframe: within 4 hours after sucrose load
Secondary Outcome
- Difference in postprandial maximum concentration (Cmax) of blood glucose and serum insulin following sucrose load with acarbose (day 1) and without acarbose (day 0)Timeframe: 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)Timeframe: within 4 hours after sucrose load
- Safety parametersAdverse events (AEs), clinical chemistry, hematology, urinalysis, physical examination, systolic and diastolic blood pressure, pulse rate, electrocardiogram (ECG)Timeframe: Assessed in pre study treatment, study treatment, and follow-up visits
Additional Information
Copyright © Bayer
Powered by
