NCT01131897已完成1 期
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr. Reddy's Levetiracetam Tablets, 750 mg and Keppra® 750 mg Tablets of UCB Pharma in Healthy Adult Male Volunteers Under Fasting Conditions.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Bioavailability based on Cmax and AUC parameters
研究概览
简要总结
The purpose of this study is to compare the single-dose relative bioavailability study of Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under Fasting conditions.
详细描述
This is an open-label, randomized, single-dose 2-way crossover relative bioavailability study in healthy adult male volunteers under fasting conditions with a washout period of 7 days.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male volunteers, 18 to 55 years of age;
- •Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Wights of Adults", Metropolitan Life Insurance Company, 1983);
- •Medically healthy subjects with clinically normal laboratory profiles and ECGs as deemed by the principal investigator;
- •Voluntarily consent to participate in the study
排除标准
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- •In addition, history or presence of:
- •alcoholism or drug abuse within the past 2 years;
- •hypersensitivity or idiosyncratic reaction to levetiracetam;
- •Subjects who have been on an special diet (for whatever reason) during the 30 days prior to the first dose and throughout the study.
- •Subjects who have made a donation (Standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to the first dose.
- •Subjects who have made a plasma donation within 7 days prior to the first dose.
- •Subjects who have participated in another clinical trial within 30 days prior to the first dose.
- •Subjects with hemoglobin less than 12.0 g/dL.
- •Subjects who have participated in another clinical trial within 30 days prior to the first dose.
研究组 & 干预措施
Levetiracetam
Experimental
Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
干预措施: Levetiracetam (Drug)
Keppra®
Active Comparator
Keppra® 750 mg Tablets of UCB Pharma Inc.,
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Bioavailability based on Cmax and AUC parameters
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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