Phase I Pharmacokinetic and Safety Study of Intravenous Topiramate in Adult Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety as measured by the occurrence of adverse events
研究概览
简要总结
The aims of this study are to determine, in adult patients on maintenance topiramate therapy, the steady-state pharmacokinetics and safety of orally and intravenously administered topiramate.
详细描述
The long-term goal of this research project is to develop a more effective, safer therapy for neonatal seizures. Prior to using an investigational intravenous topiramate formulation in children and neonates, the pharmacokinetics and safety of the formulation must be demonstrated in adults. The immediate aims of this study are to determine the pharmacokinetics and safety of a novel intravenous topiramate formulation. An additional aim is to determine if sex, advancing age, or genotype affects topiramate absorption, distribution, or elimination.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons taking topiramate
- •Persons 18 years of age and older
排除标准
- •Patients who are pregnant
- •Patients who are breast feeding
- •Patients with significant medical problems who may not tolerate intravenous administration
- •Patients taking medications known to affect topiramate disposition
研究组 & 干预措施
1
This is a one arm pharmacokinetic and safety study.
干预措施: intravenous topiramate (Drug)
结局指标
主要结局
Safety as measured by the occurrence of adverse events
时间窗: 96 hours after dosing
Occurrence of adverse events in the 4 days following Topiramate dose
次要结局
未报告次要终点