NCT01366235已完成1 期
Clinical Trial for Evaluation of Ethnic Differences in Pharmacokinetics of Chloroquine, an Anti-malarial Drug
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- pharmacokinetic evaluation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Southeast Asians
Experimental
干预措施: chloroquine phosphate 1000 mg (Drug)
Korean
Experimental
干预措施: chloroquine phosphate 1000 mg (Drug)
Caucasians
Experimental
干预措施: chloroquine phosphate 1000 mg (Drug)
Africans
Experimental
干预措施: chloroquine phosphate 1000 mg (Drug)
结局指标
主要结局
pharmacokinetic evaluation
时间窗: within 30 days
maximum of concentration(Cmax)
次要结局
- pharmacokinetic evaluations(within 30 days)
研究者
研究点 (1)
Loading locations...
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