NCT01114854已完成1 期
A Conversion Study to Determine the Relative Bioavailability of TPM MR vs TPM IR in Subjects With Epilepsy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 9
- 主要终点
- relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma
研究概览
简要总结
This multi-center, two-treatment study compares the pharmacokinetic profiles of Immediate Release (IR) and Modified Release (MR) formulations of Topiramate (TPM) in patients with epilepsy.
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
盲法说明
It was a open-label study
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female patients with epilepsy on stable doses of topiramate.
- •Able to voluntarily provide written informed consent to participate in the study.
- •Use of an effective form of birth control if of child-bearing potential.
排除标准
- •Diagnosis of status epilepticus, non-epileptic seizures, or any progressive CNS disease.
- •Recent or recurrent suicidal thoughts or ideation.
- •Clinically significant medical condition that may affect the safety of the subject.
- •Females who are pregnant or lactating.
研究组 & 干预措施
Topiramate IR followed by Topiramate ER
Other
Dosing with IR followed by dosing with ER
干预措施: Topiramate ER (Drug)
Topiramate IR followed by Topiramate ER
Other
Dosing with IR followed by dosing with ER
干预措施: Topiramate IR (Drug)
结局指标
主要结局
relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma
时间窗: 2 weeks
次要结局
- relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma(2 weeks)
研究者
研究点 (9)
Loading locations...
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