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Pharmacokinetics of Mitiglinide and Metformin in Free Combination and Fixed-dose Combination in Healthy Male Subjects.

NCT ID: NCT01443221

Last Updated: 2011-09-29

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-01-31

Brief Summary

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To investigate safety and pharmacokinetics of mitiglinide and metformin in a fixed-dose combination of mitiglinide/metformin, compared with free combination of mitiglinide and metformin in healthy male subjects.

Detailed Description

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The Korean clinical practice guidelines on DM recommend that a second oral agent with a different mechanism of action be combined to the regimen when adequate glycemic control is difficult to achieve with an oral hypoglycemic agent accompanied dietary therapy. Therefore, a concurrent administration of metformin, a inhibitor of gluconeogenesis, and mitiglinide, an insulin secretagogue, could be an effective and ideal regimen for management of diabetes.

Conditions

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Healthy

Keywords

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mitiglinide metformin Pharmacokinetics Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Free combination

Free combination of Mitiglinide 10mg and Metformin 500mg

Group Type ACTIVE_COMPARATOR

mitiglinide and metformin

Intervention Type DRUG

Free combination of Mitiglinide 10mg and Metformin 500mg

Fixed-dose combination

Fixed-dose combination of Mitiglinide 10mg and Metformin 500mg

Group Type EXPERIMENTAL

mitiglinide and metformin

Intervention Type DRUG

Fixed-dose combination of Mitiglinide 10mg and Metformin 500mg

Interventions

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mitiglinide and metformin

Free combination of Mitiglinide 10mg and Metformin 500mg

Intervention Type DRUG

mitiglinide and metformin

Fixed-dose combination of Mitiglinide 10mg and Metformin 500mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males
* Subject with adequate clinical laboratory test results (hematology, blood chemistry, serology, drug abuse, urinalysis etc.)
* Subject with normal results in blood pressure, pulse, body temperature and ECG test
* Subject with body mass index (BMI) between 18.5 kg/m2 and to 25 kg/m2

Exclusion Criteria

* Clinically significant functional disorder or acute disease
* Chronic disease affecting the absorption, metabolism or excretion of drug
* Any study drug administration within 90 days before the first drug administration
* Use of medicine affecting drug metabolism (inhibition, induction) such as barbital, within 30 days before the first drug administration
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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JW Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wooseong Hur, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CWP-KAD-05

Identifier Type: -

Identifier Source: org_study_id