Study 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

Inclusion Criteria
- 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
Exclusion Criteria
- 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

Trial Dates

September 2012 - December 2012

Phase

Phase 1

Could I Receive a placebo

Products

Glucobay M (Acarbose/Metformin, BAY81-9783)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Seoul National University Hospital	Seoul, 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)
Time Frame:
within 4 hours after sucrose load
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)
Time Frame:
within 4 hours after sucrose load
Safety Issue:
No
Cmax of metformin
Time Frame:
within 24 hours after dosing
Safety Issue:
No
AUC(0-tn) of metformin
Time Frame:
within 24 hours after dosing
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

Additional Information

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