Pharmacokinetics of a New Paediatric Formulation of Valacyclovir Used for Prophylaxis and Treatment of Varicella Zoster Virus (VZV) and Herpes Simplex Virus (HSV) Infections in Children, Phase II (VALID II)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Valacyclovir has replaced acyclovir in many clinical scenarios. Pharmacokinetic data support the use of oral valacyclovir in children, but practical problems exist in children having to take adult-dose tablets. A formulation with acceptable palatability, good pharmaceutical quality and possibility of flexible dosing is developed. Pharmacokinetic data of this formulation is missing.
The present study investigates the pharmacokinetics of valacyclovir oral solution in children by determine the area under the curve (AUC0-12), time above critical concentration (Ccrit), Cmax and Tmax of acyclovir.
Secondary, the safety profile of a single dose of valacyclovir oral solution will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is in the age of 2-12 years.
- •Subject has an indication for (val)acyclovir prophylaxis and are planned to receive valacyclovir oral solution.
- •Subject is managed with a central venous catheter (CVC/Port-a-Cath).
- •Subject's parents have signed the Informed Consent Form prior to screening evaluations.
- •Subject is willing to participate after study procedures are explained in comprehensible language for the child.
排除标准
- •Severe anemia (<6.0 mmol/L).
- •Full dose has not been taken.
研究组 & 干预措施
Valacyclovir oral solution
Valacyclovir oral solution as administered in standard of care. Dosage: 10 mg/kg BID for children weighing less than 40 kg and 500 mg BID for children weighing 40 kg or more.
干预措施: Valacyclovir (Drug)
结局指标
主要结局
Cmax
时间窗: 12 hours
Maximum concentration of aciclovir
Area under the curve
时间窗: 12 hours
Acyclovir area under the curve (12h)
Tmax
时间窗: 12 hours
Time to reach maximum concentration of aciclovir
次要结局
- Number of adverse events(1 day)