A Monocenter, Open-label, Two-way Randomized Cross-over Study to Evaluate the Bioequivalence of Levetiracetam Administered as a 45 Minutes Intravenous Infusion and Same Dosage Levetiracetam Oral Tablet (Part A); and a Randomized, Double-blind, Placebo-controlled, Parallel Study on the Safety, Tolerability and Pharmacokinetics of Levetiracetam 45 Minutes Intravenous Infusion During 4 Days of b.i.d. Dosing (Part B), in Chinese Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable concentration (AUC(0-t))
研究概览
简要总结
The part A of N01362 is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to tablet oral administration in Chinese healthy volunteers.
详细描述
The study includes 2 parts, part A is to evaluate the bioequivalence of Levetiracetam (LEV) 1500 mg intravenous (iv) infusion when compared to oral tablet, part B is to assess pharmacokinetic profile of LEV infusion during repeated dosing in Chinese healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese, age 18-40, weight ≥ 50 kg
- •Healthy volunteers with normal vital signs, good physical and mental health status and normal electrocardiogram and laboratory test
排除标准
- •History or presence of each systems disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication
- •History or presence of drug addiction or excessive use of alcohol
- •Symptomatic or asymptomatic Orthostatic Hypotension at screening
- •Current smokers and former smokers
- •Heavy caffeine drinker
- •History of frequent and severe headache
- •Any drug treatment
- •Subjects who are known to have Serum Hepatitis or who are carriers of the Hepatitis B surface antigen, or Hepatitis C antibody or who are HIV positive
- •Subjects on a controlled sodium diet
- •Subject has made a blood donation or had a comparable blood loss
研究组 & 干预措施
Levetiracetam iv infusion
Levetiracetam intravenous (iv) 45 min infusion administered as one single dose.
干预措施: Levetiracetam (Drug)
Levetiracetam oral tablet
Levetiracetam oral tablet administered as one single dose.
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable concentration (AUC(0-t))
时间窗: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
Area under the plasma drug concentration-time curve from 0 to infinity (AUC)
时间窗: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
The area under the curve extrapolated to infinity is calculated as the sum of AUC(0-t) and a residual part extrapolated to infinite time.
Maximum measured plasma concentration (Cmax)
时间窗: Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration
The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves.
次要结局
- Area under the plasma drug concentration-time curve calculated from 0 to 12 h (AUC(0-12))(Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration)
- Plasma concentration at the end of the 45-minutes intravenous (iv) infusion (C45'(iv))(Pharmacokinetic samples were taken at 45 min after Levetiracetam administration)
- Time to reach the maximum plasma concentration of Levetiracetam after administration (tmax)(Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration)
- Terminal half-life of Levetiracetam (t1/2)(Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration)
- Total body clearance after intravenous infusion of Levetiracetam (CL(iv))(Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration)
- Apparent total body clearance after oral administration of Levetiracetam (CL/F(tablet))(Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration)
- Volume of distribution after intravenous infusion of Levetiracetam (Vz(iv))(Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration)
- Apparent volume of distribution after oral administration of Levetiracetam (Vz/F(tablet))(Pharmacokinetic samples were taken from pre-dose to 36 hours after Levetiracetam administration)