Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug

NCT ID: NCT01366235

Last Updated: 2015-01-26

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-12-31

Brief Summary

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Chloroquine is an anti-malaria agent. This study is designed to evaluate inter-ethnic differences of therapeutic effect of chloroquine and search the cause of these ethnic differences. For this purpose, chloroquine will be administered to four ethic groups of Korean, Caucasian, African and Southeast Asian and chloroquine concentration in blood will be measured. The result of this study will be helpful in finding more adequate dosing regimen of chloroquine in patients with malaria.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Southeast Asians

Group Type EXPERIMENTAL

chloroquine phosphate 1000 mg

Intervention Type DRUG

1000 mg, 1day

Korean

Group Type EXPERIMENTAL

chloroquine phosphate 1000 mg

Intervention Type DRUG

1000 mg, 1day

Caucasians

Group Type EXPERIMENTAL

chloroquine phosphate 1000 mg

Intervention Type DRUG

1000 mg, 1day

Africans

Group Type EXPERIMENTAL

chloroquine phosphate 1000 mg

Intervention Type DRUG

1000 mg, 1day

Interventions

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chloroquine phosphate 1000 mg

1000 mg, 1day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* aged 20 - 50 male subjects (6 Koreans, 6 Caucasians, 6 Africans and 6 Southeast Asians)
* Subjects with body weight ≥ 45 kg and within ±20% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.9.

Exclusion Criteria

* Subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study.
* Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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http://crc.amc.seoul.kr

Clinical Research Center, Asan Medical Center

Other Identifiers

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2011-0214

Identifier Type: -

Identifier Source: org_study_id

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