Trial Condition(s):

Diabetes Mellitus, Type II

Bioequivalence study for Acarbose / Metformin FDC

Bayer Identifier:

15420

ClinicalTrials.gov Identifier:

NCT01728740

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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
40
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Glucobay M (Acarbose/Metformin, BAY81-9783)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Seoul National University Hospital

Seoul, South Korea, 110-744

Status
Completed
 

Trial Design