An Open-label Study of Excretion Balance and Pharmacokinetics Following a Single Oral Dose of [14C]-Sodium Valproate (3.7 MBq) in Healthy Postmenopausal or Permanently Sterile Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Assessment of PK parameters: Cmax
研究概览
简要总结
Primary Objectives:
- To determine the excretion balance and systemic exposure of radioactivity after oral administration of [14C]-sodium valproate (VPA) .
- To determine the pharmacokinetics of sodium VPA and metabolite(s) and its contribution to the overall exposure of radioactivity.
- To collect samples in order to determine the metabolic pathways of sodium VPA and identify the chemical structures and main excretion route of the main metabolites.
Secondary Objective:
To assess the clinical and biological tolerability of oral solution of sodium VPA.
详细描述
Total study duration is 3 to 10 weeks, including a screening period of 8 to 28 days, treatment period of up to 15 days and a follow-up and end of study of up to 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
sodium valproate
Single oral dose of sodium valproate containing [14C]-sodium VPA
干预措施: sodium valproate (Drug)
结局指标
主要结局
Assessment of PK parameters: Cmax
时间窗: Day 1 to 8, Day 12 to Day 15, Day 22, Day 29, Day 36, Day 43
Maximum plasma or blood concentration observed
Assessment of PK parameters: tmax
时间窗: Day 1 to 8, Day 12 to Day 15, Day 22, Day 29, Day 36, Day 43
Time to reach Cmax (tmax)
Assessment of key metabolite(s) of sodium valproate
时间窗: Day 1 to Day 43
key metabolite(s) of sodium valproate will be assessed in plasma, urine and feces.
Assessment of PK parameters: t1/2z
时间窗: Day 1 to 8, Day 12 to Day 15, Day 22, Day 29, Day 36, Day 43
Terminal half-life associated with the terminal slope (λz) (t1/2z) in plasma, blood radioactivity and plasma VPA
Percentage of radioactive dose excreted in urine and feces
时间窗: Day 1 to Day 43
Fractional and cumulative percentage of radioactive dose excreted in urine and feces
Assessment of PK parameters: AUClast
时间窗: Day 1 to 8, Day 12 to Day 15, Day 22, Day 29, Day 36, Day 43
Area under the plasma concentration versus time curve calculated from time zero to the real time, tlast (time corresponding to the last concentration above the limit of quantification, Clast (AUClast)
Assessment of PK parameters: B/P (blood/plasma radioactivity ratio)
时间窗: Day 1 to 8, Day 12 to Day 15, Day 22, Day 29, Day 36, Day 43
Blood to plasma radioactivity ratio calculated at each time point
Assessment of PK parameters: AUC
时间窗: Day 1 to 8, Day 12 to Day 15, Day 22, Day 29, Day 36, Day 43
Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
Assessment of PK parameters: RAUC (VPA to radioactivity ratio for plasma AUC)
时间窗: Day 1 to 8, Day 12 to Day 15, Day 22, Day 29, Day 36, Day 43
RAUC is calculated as AUC(VPA)/AUC (radioactivity)
Assessment of PK parameters: RCmax (VPA to radioactivity ratio for plasma Cmax)
时间窗: Day 1 to 8, Day 12 to Day 15, Day 22, Day 29, Day 36, Day 43
RCmax is calculated as Cmax(VPA)/Cmax (radioactivity)
次要结局
- Safety- Adverse Events(From day -1 to 43)