NCT00985348已完成1 期
Randomized, Monocenter, Open Label, Two-way Cross-over, Single Dose Bioequivalence Study of Two Oral Formulations of Levetiracetam in Healthy Male & Female Japanese Subjects
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
- 26
- 主要终点
- AUC (Area under the curve extrapolated to infinity) of Levetiracetam
研究概览
简要总结
To demonstrate the bioequivalence of a Levetiracetam dry syrup (50% (500mg/1000mg)) versus Levetiracetam 500 mg oral tablet, used as reference, after single dose administration 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
- •Written informed consent dated and signed by subject.
- •Healthy male or female Japanese volunteer from the first generation, living outside of Japan for less than 10 years, age range 20 to 55 years inclusive.
- •Body Mass Index (BMI) between 18.0 and 28.0 kg/m² inclusive.
排除标准
- •Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method.
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, neurological, psychiatric disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication.
- •History of drug addiction or presence of drug addiction (positive drug screen) or excessive use of alcohol (weekly intake in excess of 21 units alcohol for male and 14 units alcohol for female; one unit alcohol equals one glass of beer or lager, a glass of wine or a measure of spirits), of psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
- •Heavy caffeine drinker (drinking >5 cups of coffee or equivalent, approximately 500mg of caffeine per day).
- •Smokers of more than 10 cigarettes per day or smokers not willing to abstain from smoking while in the clinic for each period.
研究组 & 干预措施
Treatment 1/Treatment 2
Experimental
干预措施: Levetiracetam (Keppra) (Drug)
Treatment 2/Treatment 1
Experimental
干预措施: Levetiracetam (Keppra) (Drug)
结局指标
主要结局
AUC (Area under the curve extrapolated to infinity) of Levetiracetam
时间窗: 36 hours
Cmax (maximum plasma concentration) of Levetiracetam.
时间窗: 36 hours
AUC (0-t) (Area under the plasma concentration vs. time curve observed from time 0 h up to the last measurable data point) of Levetiracetam
时间窗: 36 hours
次要结局
- λz (Terminal elimination rate constant) of Levetiracetam(36 hours)
- tmax (time of maximum plasma concentration) of Levetiracetam(36 hours)
- t1/2 (Terminal elimination half-life) of Levetiracetam(36 hours)
- MRT (Mean Residence Time) of Levetiracetam(36 hours)
- CL/F (Apparent total body clearance) of Levetiracetam(36 hours)
- Vz/F (Apparent volume of distribution) of Levetiracetam(36 hours)
研究者
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