NCT01394224已完成1 期
A Single Site, Open-label, Randomized, Single-dose, Two-way Cross-over Study in Healthy Japanese Subjects to Evaluate the Bioequivalence, Safety & Tolerability of Levetiracetam Administered as an Oral Tablet or Intravenous Infusion
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 25
- 主要终点
- Maximum drug concentration (Cmax)
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg and a single oral dose(tablets) of 1500 mg in healthy Japanese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese male and female volunteers with the age between 20 and 55 years old
排除标准
- •Subject has participated or is participating in any other clinical studies of investigational drug or another IMP within the last 3 months
- •Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
- •Subject is pregnant or lactating female.
研究组 & 干预措施
Levetiracetam IV Infusion (1500 mg)
Experimental
干预措施: Levetiracetam (Drug)
Levetiracetam tablets (1500 mg)
Experimental
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Maximum drug concentration (Cmax)
时间窗: Multiple sampling from 0 to 36 hours following single dose
Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUCo-t)
时间窗: Multiple sampling from 0 to 36 hours (could be less than 36 hours if the last quantifiable concentration is below limit of quantification), following single dose
次要结局
- Time to reach maximum plasma concentration (tmax)(Multiple sampling from 0 to 36 hours following single dose)
- Plasma concentration at the end of infusion (C15' )(At 15 minutes after termination of the15-minutes infusion)
- Area under the curve from 0 to infinity (AUC)(Multiple sampling from 0 to 36 hours following single dose)
- Mean resident time (MRT)(Multiple sampling from 0 to 36 hours following single dose)
- Terminal elimination half-life(t1/2)(Multiple sampling from 0 to 36 hours following single dose)
- First order terminal elimination rate constant (λz )(Multiple sampling from 0 to 36 hours following single dose)
- Total body clearance after oral administration (CL/F) or after IV infusion (CL)(Multiple sampling from 0 to 36 hours following single dose)
- Volume of distribution after oral administration(Vz/F) or after IV infusion(Vz)(Multiple sampling from 0 to 36 hours following single dose)
研究者
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