check_circleStudy Completed

Diabetes Mellitus, Type II

Bayer Identifier:

15420

ClinicalTrials.gov Identifier:

NCT01728740

EudraCT Number:

Not Available

EU CT Number:

Not Available
Bioequivalence study for Acarbose / Metformin FDC

Trial purpose

To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Body Mass Index (BMI): 18 to 28 kg/m2 (inclusive)
    - Results of Glycosylated Hemoglobin A1c (HbA1c) value are within the normal range (4.3–5.6%, inclusive)
    - Results of the 75 g oral glucose tolerance test (OGTT) during screening show:
     -- Blood glucose before OGTT <110 mg/dL.
     -- Blood glucose 1 hour after glucose loading <180 mg/dL
     -- Blood glucose 2 hours after glucose loading <140 mg/dL

  • - A history of relevant diseases of internal organs (diabetes mellitus, Ileus, Ileus-like symptoms, diseases that may significantly jeopardize body systems
    - Febrile illness within 1 week before drug administration
    - Family history of diabetes (within the second degree of relationship)
    - Known drug hypersensitivity or idiosyncrasy
    - Known severe allergies, non-allergic drug reactions, or multiple drug allergies
    - Habitual medication including Chinese herbal drugs
    - Intake of any drugs within 2 weeks of drug administration of period 1
    - Regular daily consumption of more than 1 L of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form
    - Donation of more than 150 mL of blood within 4 weeks before the screening examination
    - Participation in another clinical trial within 4 weeks before the screening examination

Trial summary

Enrollment Goal
40
Trial Dates
September 2012 - December 2012
Phase
Phase 1
Could I Receive a placebo
No
Products
Glucobay M (Acarbose/Metformin, BAY81-9783)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of

Primary Outcome

  • Ratio of postprandial maximum concentration (Cmax) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
    date_rangeTime Frame:
    within 4 hours after sucrose load
    enhanced_encryption
    Safety Issue:
    No
  • Ratio of postprandial Area Under the Curve (AUC(0 4)) of plasma glucose following sucrose load with (Day 1) and without acarbose (Day 0)
    date_rangeTime Frame:
    within 4 hours after sucrose load
    enhanced_encryption
    Safety Issue:
    No
  • Cmax of metformin
    date_rangeTime Frame:
    within 24 hours after dosing
    enhanced_encryption
    Safety Issue:
    No
  • AUC(0-tn) of metformin
    date_rangeTime Frame:
    within 24 hours after dosing
    enhanced_encryption
    Safety Issue:
    No

Trial design

Randomized, non-blinded crossover study to establish the bioequivalence between fixed dose combination (FDC) and loose combination of Acarbose and Metformin and to investigate the potential for a drug-drug interaction following single oral dosing in healthy adult male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
4

Additional Information

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