NCT00926302已完成不适用
A Randomized, Single, Two-Way Crossover Pivotal Study to Assess the Bioequivalence Study of Levetiracetam vs. Keppra Administered Under Fasting Conditions to Healthy Adult Subject
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- To assess the bioequivalence
研究概览
简要总结
The purpose of this study is to assess the bioequivalence of Levetiracetam versus Keppra administered under fasting conditions to healthy adult subjects.
详细描述
This study is a randomized, single, two-way crossover pivotal study. The pharmacokinetic blood samples and vital signs were obtained before and after administration at scheduled intervals as indicated in the study protocol.
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed written informed consent before enrollment into the study, ability to communicate with the investigators, and to understand and comply with the requirements of the study.
- •Healthy adult male, aged between 20 and 40 years old.
- •Body Mass Index between 18.5 and 25 (inclusive).
- •Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
- •No significant deviation from normal biochemistry examination.
- •No significant deviation from normal hematology examination.
- •No significant deviation from normal urinalysis examination.
排除标准
- •History of drug or alcohol abuse within the past year.
- •Medical history of severe drug allergy or sensitivity to analogous drug.
- •Evidence of acute or chronic disease or having undergone surgery from 4 weeks prior to Period I dosing.
- •Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
- •Ongoing peptic ulcer and constipation.
- •Planned vaccination during the time course of the study.
- •Taking any clinical investigation drug from 2 months prior to Period I dosing.
- •Use of any medication, including herb medicine or vitamins from 4 weeks before the study.
- •Blood donation of more than 500 mL within the past 3 months.
- •A positive Hepatitis B surface antigen or positive Hepatitis C antibody result.
- •A positive test for HIV antibody.
研究组 & 干预措施
Test drug
Experimental
Levetiracetam one period
干预措施: Levetiracetam (Lotus Pharmaceutical Co.,Ltd.) (Drug)
Reference drug
Active Comparator
Keppra one period
干预措施: Keppra (Levetiracetam - USB SA Pharma Sector) (Drug)
结局指标
主要结局
To assess the bioequivalence
时间窗: 48 hours
次要结局
未报告次要终点
研究者
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