NCT02289274撤回1 期
Partial Replicated Crossover Clinical Study to Compare Pharmacokinetic Characteristics of Eperisone and Aceclofenac With NVP-1203 Treatment to Those of Co-administration of Eperisone Hydrochloride Slow Release and Aceclofenac in Volunteers
NVP Healthcare1 个研究点 分布在 1 个国家开始时间: 2019年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Area Under Curve(AUC) last
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics of NVP-1203 and coadministration of aceclofenac and eperisone HCl SR.
详细描述
aceclofenac and eperisone(low back pain)
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
- 19 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, age between 19 and 45
- •BMI of >19kg/m2 and <28kg/m2 subject
- •Informed of the investigational nature of this study and voluntarily agree to participate in this study
排除标准
- •Use of any prescription medication within 14 days prior to Day 1
- •Use of any medication within 7 days prior to Day 1
研究组 & 干预措施
NVP-1203
Experimental
NVP-1203
干预措施: NVP-1203 (Drug)
Eperisone SR tab. + and Airtal tab.
Active Comparator
Eperisone HCl and aceclofenac
干预措施: Eperisone SR tab. + and Airtal tab. (Drug)
结局指标
主要结局
Area Under Curve(AUC) last
时间窗: 0-24hr
次要结局
未报告次要终点
研究者
研究点 (1)
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