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Completed

NCT Number: NCT01366235

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

chloroquine phosphate 1000 mg

Drug

1000 mg, 1day

Primary outcomes

  1. pharmacokinetic evaluation

    Time frame: within 30 days

    maximum of concentration(Cmax)

Secondary outcomes

  1. pharmacokinetic evaluations

    Time frame: within 30 days

    Area under the time-concentration curve(AUC)

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 6, 2011
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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