A Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study, of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics (PK) and Safety in Acute Pain and Fever
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 75
- 试验地点
- 5
- 主要终点
- Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen
研究概览
简要总结
We are doing this study to find out what happens to acetaminophen in the body after it is given to children through the vein. Children's bodies may handle drugs differently than adults. Understanding how long the drug stays in the body and how the drug is changed or metabolized by the body (called pharmacokinetics) is an important step in learning what the best dose of acetaminophen for children should be. We are also interested in learning about the safety of this medication when given to children.
详细描述
A Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study, of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics (PK) and Safety in Acute Pain and Fever
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 29 Days 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intravenous (IV) Acetaminophen 15 milligrams/kilogram (mg/kg)
Intravenous Acetaminophen administered 15 milligrams/kilogram (mg/kg) every 8 hours (q8h) or every 6 hours (q6h) based age of subject
干预措施: IV Acetaminophen (Drug)
Intravenous (IV) Acetaminophen 12.5 (mg/kg)
Intravenous Acetaminophen administered 12.5 milligrams/kilogram (mg/kg) every 6 hours (q6h) or every 4 hours (q4h)
干预措施: IV Acetaminophen (Drug)
结局指标
主要结局
Single-dose Maximum Plasma Concentration (Cmax) , Micrograms Per Milliliter (µg/mL) Pharmacokinetics of IV Acetaminophen
时间窗: Time Zero (just prior to first dose) to 24 hours post first dose
Cmax: Maximum Plasma Concentration
Single-dose Time to Reach Maximum Plasma Concentration [Tmax(h)] Pharmacokinetics of IV Acetaminophen
时间窗: Time Zero (just prior to first dose) to 24 hours post first dose
Tmax: Time to reach maximum plasma concentration (Cmax)
Multiple-dose Terminal Elimination Half-life [t1/2(h)] Pharmacokinetics of IV Acetaminophen
时间窗: 48hrs
t1/2: Terminal elimination half-life
Multiple-dose Area Und the Curve (AUC) From Time 0 (Predose) to the Time of the Dosing Interval at Steady-state (0-t (µg*h/ml) Pharmacokinetics of IV Acetaminophen
时间窗: Time Zero (just prior to first dose) to 48 hours post first dose
AUC 0-t (µg\*h/ml): Area under the plasma concentration versus time curve from time 0 (predose) to the time of the dosing interval at steady-state.
次要结局
- Subjects Who Experience at Least One Serious Treatment-Emergent Adverse Event (TEAE)(First dose to 30 days following last dose of study medication)
- Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE)(First dose of study medication to 30 days after the last dose of study medication)