A Multicenter, Open-label, Single-arm Study to Evaluate the Single-dose Pharmacokinetics, Acceptability and Safety of Famciclovir Oral Pediatric Formulation in Infants 1 Month to Less Than 1 Year of Age With Herpes Simplex Virus Infections
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 18
- 试验地点
- 6
- 主要终点
- Pharmacokinetics of Single Dose - Tmax
研究概览
简要总结
This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection
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 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients from 1 month up to 1 year of age with herpes simplex infection
排除标准
- •Patients with gestational age less than 32 weeks. Patients unable to swallow. Patients with history of malabsorption or previous gastrointestinal surgery.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Famciclovir
Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
干预措施: famciclovir (Drug)
结局指标
主要结局
Pharmacokinetics of Single Dose - Tmax
时间窗: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.
Pharmacokinetics of Single Dose - Cmax
时间窗: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Measured by Cmax - The maximum plasma concentration of study medication
Pharmacokinetics of Single Dose - AUC(0-tlast)
时间窗: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.
Pharmacokinetics of Single Dose - AUC(0-6h)
时间窗: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing.
Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample).
次要结局
- Safety Assessed by AEs, SAEs(38 days)
- Safety Assessed by Labs(2 days)
- Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel.(30 minutes after dosing)
- Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver(Immediately after dosing)
- Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel(Immediately after dosing)