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

This study has been completed.
Information provided by:
Asan Medical Center Identifier:
First received: May 31, 2011
Last updated: January 23, 2015
Last verified: May 2011
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.

Condition Intervention Phase
Healthy Volunteers
Drug: chloroquine phosphate 1000 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug

Resource links provided by NLM:

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • pharmacokinetic evaluation [ Time Frame: within 30 days ]
    maximum of concentration(Cmax)

Secondary Outcome Measures:
  • pharmacokinetic evaluations [ Time Frame: within 30 days ]
    Area under the time-concentration curve(AUC)

Enrollment: 10
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Southeast Asians Drug: chloroquine phosphate 1000 mg
1000 mg, 1day
Experimental: Korean Drug: chloroquine phosphate 1000 mg
1000 mg, 1day
Experimental: Caucasians Drug: chloroquine phosphate 1000 mg
1000 mg, 1day
Experimental: Africans Drug: chloroquine phosphate 1000 mg
1000 mg, 1day


Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01366235

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
  More Information

Additional Information: Identifier: NCT01366235     History of Changes
Other Study ID Numbers: 2011-0214
Study First Received: May 31, 2011
Last Updated: January 23, 2015

Additional relevant MeSH terms:
Chloroquine diphosphate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents
Amebicides processed this record on May 25, 2017