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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: chloroquine phosphate 1000 mg

• Registration Number: NCT01366235
• Lead Sponsor: Asan Medical Center

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2011-05
• Study Start: 2011-05
• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-06
• Primary Completion: 2011-10
• Study Completion: 2011-12
• Last Update Submitted: 2015-01-23
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Southeast Asians	chloroquine phosphate 1000 mg	-
Caucasians	chloroquine phosphate 1000 mg	-
Africans	chloroquine phosphate 1000 mg	-
Korean	chloroquine phosphate 1000 mg	-

Primary Outcome Measures

Name	Time	Method
pharmacokinetic evaluation	within 30 days	maximum of concentration(Cmax)

Secondary Outcome Measures

Name	Time	Method
pharmacokinetic evaluations	within 30 days	Area under the time-concentration curve(AUC)

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of