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Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-Drug Interaction of Pyrimethamine and Metformin IR

NCT ID: NCT01973933

Last Updated: 2013-11-01

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Brief Summary

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This study aims to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of pyrimethamine and metformin IR after oral administration in healthy male volunteers.

Detailed Description

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Conditions

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Healthy

Keywords

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Metformin Pyrimethamine Drug interaction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin and Pyrimethamine

Metformin 750mg(D1), Metformin 500mg(D2)/Metformin 750mg+Pyrimethamine 50mg(D7), Metformin 500mg+Pyrimethamine 50mg(D8)

Group Type EXPERIMENTAL

Metformin and Pyrimethamine

Intervention Type DRUG

Interventions

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Metformin and Pyrimethamine

Intervention Type DRUG

Other Intervention Names

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Diabex Daraprim

Eligibility Criteria

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Inclusion Criteria

* healthy male subject aged 20 to 45 at screening A body weight in the range of 50 kg (inclusive)
* 100 kg (inclusive) with ideal body weight range of +- 25% subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria

* subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* Subject judged not eligible for study participation by investigator.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae Yong Chung

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae-Yong Chung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seoul, Korea

Locations

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Seoul National University Bundang Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MPI02

Identifier Type: -

Identifier Source: org_study_id