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

Asan Medical Center

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: chloroquine phosphate 1000 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01366235

2011-0214

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 4 patient groups

Southeast Asians

Experimental group

Treatment:

Drug: chloroquine phosphate 1000 mg

Korean

Experimental group

Treatment:

Drug: chloroquine phosphate 1000 mg

Caucasians

Experimental group

Treatment:

Drug: chloroquine phosphate 1000 mg

Africans

Experimental group

Treatment:

Drug: chloroquine phosphate 1000 mg