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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2011 by Asan Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Asan Medical Center

ClinicalTrials.gov Identifier:

NCT01366235

First received: May 31, 2011

Last updated: June 2, 2011

Last verified: May 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 31, 2011
Last Updated Date	June 2, 2011
Start Date ^ICMJE	May 2011
Estimated Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 2, 2011)	pharmacokinetic evaluation [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ] maximum of concentration(Cmax)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01366235 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 2, 2011)	pharmacokinetic evaluations [ Time Frame: within 30 days ] [ Designated as safety issue: Yes ] Area under the time-concentration curve(AUC)
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug
Official Title ^ICMJE	Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Healthy Volunteers
Intervention ^ICMJE	Drug: chloroquine phosphate 1000 mg 1000 mg, 1day
Study Arm (s)	Experimental: Southeast Asians Intervention: Drug: chloroquine phosphate 1000 mg Experimental: Korean Intervention: Drug: chloroquine phosphate 1000 mg Experimental: Caucasians Intervention: Drug: chloroquine phosphate 1000 mg Experimental: Africans Intervention: Drug: chloroquine phosphate 1000 mg
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	24
Estimated Completion Date	September 2011
Estimated Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Male
Ages	20 Years to 50 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01366235
Other Study ID Numbers ^ICMJE	2011-0214
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Asan Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Asan Medical Center
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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