Mönchengladbach, North Rhine-Westphalia, 41061, Germany
NCT Number: NCT01388153
A 3-fold Crossover Bioequivalence Study Between Glucobay Orally Disintegrating Tablet (ODT) and Glucobay Standard Tablet
To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) taken without or with water and the Glucobay standard tablet taken with water
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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Acarbose (Glucobay ODT, BAYG5421)
DrugDay 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
Acarbose (Glucobay, BAYG5421)
DrugDay 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
Primary outcomes
-
Difference of postprandial maximum concentration (Cmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)
Time frame: 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)
Time frame: within 4 hours after sucrose load
Secondary outcomes
-
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)
Time frame: within 4 hours after sucrose load
-
Difference of postprandial Cmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)
Time frame: 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)
Time frame: within 4 hours after sucrose load
-
Tmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)
Time frame: within 4 hours after sucrose load
Sponsors and collaborators
Lead sponsor
Bayer
Industry
Registry information
Official study 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
Important dates
- Study start
- 2011
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Jul 6, 2011
- Registry last updated
- Aug 28, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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