NCT01894412已完成1 期
A Randomized, Double-blind, Single-dosing, Crossover Study to Compare the Safety and Pharmacokinetic Characteristics of HD203 25 mg With Those of Enbrel® Injection 25 mg After Subcutaneous Injection in Healthy Male Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
研究概览
简要总结
The purpose of this study is to compare the safety and pharmacokinetic characteristics of HD203 liquid with those of etanercept (enbrel) prefilled injection after subcutaneous injection
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •20 to 40 years of healthy volunteers
排除标准
- •Subject who had been treated with Etanercept before
研究组 & 干预措施
Enbrel
Active Comparator
prefilled syringe
干预措施: Etanercept (Enbrel) (Biological)
HD 203
Experimental
prefilled syringe
干预措施: HD203 (Biological)
HD 203
Experimental
prefilled syringe
干预措施: Etanercept (Enbrel) (Biological)
Enbrel
Active Comparator
prefilled syringe
干预措施: HD203 (Biological)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
时间窗: up to 56 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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