An Open-label, Single-dose, Multicenter, Pharmacokinetic, Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Plasma acyclovir and valaciclovir concentrations pre-dose (within 15 minutes of dose administration) and at 0.5, 1, 2, 4 and 6 hours following administration of the valaciclovir oral suspension dose.
研究概览
简要总结
Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An extemporaneous suspension formulation of valaciclovir has been developed to expedite the provision of benefits to children similar to those from administration of valaciclovir solid formulations in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 6 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
Cohort 1
Subjects in the age group of 2 to less than 6 years will be included
干预措施: Valaciclovir (Drug)
Cohort 2
Subjects in the age group of 1 to less than 2 years will be included
干预措施: Valaciclovir (Drug)
Cohort 3
Subjects in the age group of 6 months to less than 1 year will be included
干预措施: Valaciclovir (Drug)
Cohort 4
Subjects in the age group of 3 months to less than 6 months will be included
干预措施: Valaciclovir (Drug)
Cohort 5
Subjects in the age group of 1 month to less than 3 months will be included
干预措施: Valaciclovir (Drug)
结局指标
主要结局
Plasma acyclovir and valaciclovir concentrations pre-dose (within 15 minutes of dose administration) and at 0.5, 1, 2, 4 and 6 hours following administration of the valaciclovir oral suspension dose.
时间窗: 0.5, 1, 2, 4 and 6 hours
次要结局
- Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication.(Up to Day 5)