check_circleStudy Completed

Diabetes Mellitus, Type 2

Bayer Identifier:

16025

ClinicalTrials.gov Identifier:

NCT01554631

EudraCT Number:

2012-000245-12

EU CT Number:

Not Available
A 3-fold crossover bioequivalence study between Glucobay ODT (Orally Disintegrating Tablet) 100 mg and Glucobay standard tablet 100 mg

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.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - 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
  • - 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
34
Trial Dates
March 2012 - May 2012
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

  • Ratio of postprandial maximum concentration (Cmax) of blood glucose following sucrose load with Glucobay (Day 1) and without Glucobay (Day 0)
    date_rangeTime Frame:
    within 4 hours after sucrose load
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    within 4 hours after sucrose load
    enhanced_encryption
    Safety Issue:
    No

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)
    date_rangeTime Frame:
    within 4 hours after sucrose load
    enhanced_encryption
    Safety Issue:
    No
  • 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)
    date_rangeTime Frame:
    within 4 hours after sucrose load
    enhanced_encryption
    Safety Issue:
    No
  • Safety parameters
    Adverse events (AEs), clinical chemistry, hematology, urinalysis, physical examination, systolic and diastolic blood pressure, pulse rate, electrocardiogram (ECG)
    date_rangeTime Frame:
    Assessed in pre study treatment, study treatment, and follow-up visits
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

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