NCT01775566已完成不适用
A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of Eperisone HCl SR Tablet 75mg and Myonal Tablet 50mgafter Oral Administration in Healthy Male Subjects.
NVP Healthcare1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2013年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Auclast, Cmax
研究概览
简要总结
The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetic of the Eperisone HCl SR and Myonal in healthy Korean male adults.
详细描述
Myonal: Eperisone Hydrochloride (muscle relaxant)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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 singed 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
Auclast, Cmax
时间窗: Eperisone SR 0-24h, Myonal 0-24hr
次要结局
- AUCinf, Tmax, t1/2, Css,min, Tss,max(Eperisone SR 0-24hr, Myonal 0-24hr)
研究者
研究点 (1)
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