NCT03238560Unknown不适用
Population Pharmacokinetics of Montelukast in Infants and Children
Shandong University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- bronchoalveolar lavage fluid(BALF)
研究概览
简要总结
The investigators' aim was to evaluate the population pharmacokinetics of montelukast in infants and children and define the appropriate dose in order to optimize Montelukast treatment in this vulnerable population.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients have been diagnosed with asthma; age range: 1 month to 12 years old; montelukast used as part of regular treatment.
排除标准
- •expected survival time less than the treatment cycle; patients with other factors that researcher considers unsuitable for inclusion.
结局指标
主要结局
bronchoalveolar lavage fluid(BALF)
时间窗: Procedure (When the patient underwent fiberoptic bronchoscopy)
To detect the concentrations of montelukast in bronchoalveolar lavage fluid
plasma concentration
时间窗: 3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration
To detect the plasma concentrations of montelukast at 3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration.
次要结局
未报告次要终点
研究者
Wei Zhao
Head of department of clinical pharmacy and pharmacology
Shandong University
研究点 (1)
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