A Single-center, Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Levetiracetam Administered as Intravenous Infusion in Japanese and Caucasian Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area under the curve from zero to the time of the last quantifiable concentration after a single (AUC(0-t))
研究概览
简要总结
To compare the pharmacokinetics of levetiracetam following single and multiple 15-minute intravenous infusions of 1500 mg levetiracetam between Japanese and Caucasian healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy Japanese and Caucasian males with the age between 20 and 40 years old,
- •with the body mass index between 20 and 25,
- •with the body weight between 60 and 80kg
排除标准
- •subjects who have a history or presence of drug addiction or excessive use of alcohol
- •current smokers and former smokers who have given up since less than 6 months before the first dose
- •heavy caffeine drinker
研究组 & 干预措施
Levetiracetam IV infusions in Japanese
Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Japanese subjects
干预措施: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam (Drug)
Levetiracetam IV infusions in Caucasian
Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Caucasian subjects
干预措施: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam (Drug)
结局指标
主要结局
Area under the curve from zero to the time of the last quantifiable concentration after a single (AUC(0-t))
时间窗: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
Area under the plasma concentration time curve from zero to infinity after a single dose (AUC)
时间窗: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
Body-weight normalized maximum plasma concentration after a single dose (Cmax)
时间窗: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
Body-weight normalized area under the curve from zero to the time of the last quantifiable concentration after a single, (AUC(0-t))
时间窗: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
Maximum plasma concentration after a single dose (Cmax)
时间窗: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of Intravenous (IV) infusion
Maximum plasma concentration at steady state after multiple doses (Cmax,ss)
时间窗: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
Area under the curve over a dosing interval at steady state after multiple doses (AUCτss)
时间窗: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
Body weight normalized area under the plasma concentration time curve from zero to infinity after a single dose, (AUC)
时间窗: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
Body-weight normalized maximum plasma concentration at steady state after multiple doses (Cmax,ss)
时间窗: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
Body-weight normalized area under the curve over a dosing interval at steady state after multiple doses (AUCτss)
时间窗: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
次要结局
- Accumulation ratio (RAUC) after multiple doses(Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of the first and the last IV infusions)
- Terminal elimination half-life after a single dose (t1/2)(Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.)
- First order terminal elimination rate constant after a single dose (λz)(Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.)
- Time to maximum plasma concentration at steady state after multiple doses (tmax,ss)(Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.)
- Total body clearance at steady state after multiple doses (CLss)(Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.)
- Time to maximum plasma concentration after a single dose (tmax)(Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.)
- Mean residence time after a single dose (MRT)(Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.)
- Linearity factor after multiple doses (LF)(Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of the first IV infusion and at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of the last IV infusion.)
- Area under the curve over a dosing interval, (AUCτ (τ = 12 hours))(Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion)
- Total body clearance after a single dose (CL)(Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.)
- Volume of distribution during terminal phase after a single dose (Vz)(Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.)