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-time curve over a dosing interval (AUCτ)
研究概览
简要总结
The part B of N01362 is to assess the pharmacokinetic profile of Levetiracetam 1500 mg intravenous (iv) infusion during repeated dosing 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 the 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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) infusion.
干预措施: Levetiracetam (Drug)
Placebo infusion
干预措施: Placebo (Other)
结局指标
主要结局
Area under the plasma drug concentration-time curve over a dosing interval (AUCτ)
时间窗: Pharmacokinetic samples were taken 36 hours after iv administration on Day 7
The AUCτ is the area under the plasma concentration, after the last intravenous (iv) dose, versus time curve observed during the dosing interval τ.
Maximum measured plasma concentration (Cmax)
时间窗: Pharmacokinetic samples were taken 36 hours after iv administration on Day 7
The value of the maximum plasma concentration is directly obtained from the observed plasma concentration versus time curves.
次要结局
- Plasma concentration at the end of the 45-minutes intravenous (iv) infusion (C45'(iv))(Pharmacokinetic samples were taken 36 hours after iv administration on Day 7)
- Minimum plasma concentration over dosing interval after intravenous (iv) infusion (Cmin)(Pharmacokinetic samples were taken 36 hours after iv administration on Day 7)
- Terminal half-life (t1/2)(Pharmacokinetic samples were taken 36 hours after iv administration on Day 7)