NCT01885520已完成1 期
A Randomized,Open-label, Single-dose, Crossover Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of Eperisone HCl SR Tablet 75mg After Oral Administration in Healthy Adult Male Subjects.
NVP Healthcare1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2013年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
The purpose of this study is to evaluate the food effect on the pharmacokinetics of eperisone HCl SR tablet
详细描述
eperisone hydrochloride(muscle relaxant)
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects age between 20 and 55 signed informed consent
排除标准
- •Hypotension or hypertension has a history of allergy reaction of this drug or other drugs
结局指标
主要结局
AUC
时间窗: 0-24h
Cmax
时间窗: 0-24h
次要结局
- Tmax(0-24h)
- T1/2(0-24h)
研究者
研究点 (1)
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