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Bioequivalence Study for Acarbose / Metformin FDC

NCT ID: NCT01728740

Last Updated: 2012-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-12-31

Brief Summary

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

Detailed Description

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Conditions

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Diabetes Mellitus, Type II

Keywords

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Bioequivalence Acarbose Metformin FDC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Acarbose/Metformin FDC

Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Acarbose/Metformin FDC; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose/Metformin FDC (containing 50 mg Acarbose and 500 mg Metformin)

Group Type EXPERIMENTAL

Acarbose/Metformin FDC (BAY81-9783)

Intervention Type DRUG

Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose

Acarbose+Metformin

Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without loose combination of Acarbose and Metformin; Day 1: oral sucrose load plus single dose of 1 tablet each of a loose combination of Acarbose 50 mg and Metformin 500 mg

Group Type ACTIVE_COMPARATOR

Acarbose (Glucobay, BAYG5421)

Intervention Type DRUG

Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose

Metformin

Intervention Type DRUG

Metformin 500mg, oral, single dose

Acarbose

Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Acarbose 50 mg

Group Type ACTIVE_COMPARATOR

Acarbose (Glucobay, BAYG5421)

Intervention Type DRUG

Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose

Metformin

Day 0: oral sucrose load (75 g sucrose dissolved in 225 mL water) without comedication; Day 1: oral sucrose load plus single dose of 1 tablet Metformin 500 mg

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Metformin 500mg, oral, single dose

Interventions

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Acarbose/Metformin FDC (BAY81-9783)

Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose

Intervention Type DRUG

Acarbose (Glucobay, BAYG5421)

Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose

Intervention Type DRUG

Metformin

Metformin 500mg, oral, single dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Bayer Healthcare AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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15420

Identifier Type: -

Identifier Source: org_study_id