NCT00264615已完成3 期
An Open-label, Double Conversion Study to Characterize the Pharmacokinetics of Lamotrigine When Switching Patients With Epilepsy on LAMICTAL Immediate-release to Extended-release Formulation and Vice Versa
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 13
- 主要终点
- Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine
研究概览
简要总结
Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.
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
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Females of childbearing potential cannot be on hormonal contraceptives or hormone replacement therapy.
结局指标
主要结局
Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine
次要结局
- Tmax and fluctuation index of lamotrigine
- Adverse events, changes in blood pressure and heart rate
- Change in seizure frequency during each of the study phases
- Subject preference at End of Baseline and Extended-Release Treatment Phases
研究者
研究点 (13)
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