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

NCT01366235 | Completed Phase 1

• 1 other identifier: 2011-0214
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• pharmacokinetic evaluation

  maximum of concentration(Cmax)

  within 30 days

Secondary Outcomes (1)

• pharmacokinetic evaluations

  within 30 days

Study Arms (4)

Southeast Asians

EXPERIMENTAL

Drug: chloroquine phosphate 1000 mg

Korean

EXPERIMENTAL

Drug: chloroquine phosphate 1000 mg

Caucasians

EXPERIMENTAL

Drug: chloroquine phosphate 1000 mg

Africans

EXPERIMENTAL

Drug: chloroquine phosphate 1000 mg

Interventions

chloroquine phosphate 1000 mg DRUG

1000 mg, 1day

Africans; Caucasians; Korean; Southeast Asians

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Links

• Clinical Research Center, Asan Medical Center

MeSH Terms

Interventions

chloroquine diphosphate

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 6, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 26, 2015

Record last verified: 2011-05

Locations

KR (1)