NCT03481881招募中不适用
Pharmacokinetics of Drugs Administered to Children Per Standard of Care
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Area under the curve (AUC)
研究概览
简要总结
This is a prospective study of children <21 years of age with the goal of characterizing the PK of drugs administered per standard of care as prescribed by the treating caregiver.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 20 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver
排除标准
- •Failure to obtain consent/assent (as indicated)
结局指标
主要结局
Area under the curve (AUC)
时间窗: Data will be collected throughout the hospital or outpatient stay up to 90 days
次要结局
- Maximum concentration (Cmax)(Data will be collected throughout the hospital or outpatient stay up to 90 days)
- Time to achieve maximum concentration (Tmax)(Data will be collected throughout the hospital or outpatient stay up to 90 days)
- Absorption rate constant (ka)(Data will be collected throughout the hospital or outpatient stay up to 90 days)
- Elimination rate constant (kel)(Data will be collected throughout the hospital or outpatient stay up to 90 days)
- Half-life (t1/2)(Data will be collected throughout the hospital or outpatient stay up to 90 days)
研究者
研究点 (1)
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