check_circleStudy Completed

Diabetes Mellitus, Type 2

Bayer Identifier:

15624

ClinicalTrials.gov Identifier:

NCT01388153

EudraCT Number:

2011-000904-17

EU CT Number:

Not Available
A 3-fold crossover bioequivalence study between Glucobay Orally Disintegrating Tablet (ODT) and Glucobay standard tablet

Trial purpose

To establish the bioequivalence between Glucobay ODT (Orally Disintegrating Tablet) taken without or with water and the Glucobay standard tablet taken with water

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - 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
  • - 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
33
Trial Dates
June 2011 - August 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
Glucobay ODT (Acarbose, BAYG5421)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
CRS Clinical-Research-Services Mönchengladbach GmbHMönchengladbach, 41061, Germany

Primary Outcome

  • Difference of postprandial maximum concentration (Cmax) of blood glucose following sucrose load without (Day 1) and with Glucobay (Day 2)
    date_rangeTime Frame:
    within 4 hours after sucrose load
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    within 4 hours after sucrose load
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • 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)
    date_rangeTime Frame:
    within 4 hours after sucrose load
    enhanced_encryption
    Safety Issue:
    No
  • Difference of postprandial Cmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)
    date_rangeTime Frame:
    within 4 hours after sucrose load
    enhanced_encryption
    Safety Issue:
    No
  • Difference of postprandial AUC(0-4) of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)
    date_rangeTime Frame:
    within 4 hours after sucrose load
    enhanced_encryption
    Safety Issue:
    No
  • Tmax of serum insulin following sucrose load without (Day 1) and with Glucobay (Day 2)
    date_rangeTime Frame:
    within 4 hours after sucrose load
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
3

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.