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

Condition(s) targeted: Healthy Volunteers

Intervention: chloroquine phosphate 1000 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Asan Medical Center

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.

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: pharmacokinetic evaluation

Secondary outcome: pharmacokinetic evaluations

Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Male.

Criteria:

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.

Asan Medical Center, Seoul, Korea, Republic of

Clinical Research Center, Asan Medical Center

Starting date: May 2011
Last updated: January 23, 2015