NCT01145950已完成1 期
A Randomized, Double-blind, Single-dosing, 2-way Cross-over Study to Compare the Safety and Pharmacokinetic Characteristics of LBEC0101 25 mg With Those of Enbrel® Injection 25 mg After Subcutaneous Injection in Healthy Male Volunteers
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2010年6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
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Etanercept levels in blood
研究概览
简要总结
To compare the pharmacokinetic characteristic of LBEC0101 25mg with the active comparator, Enbrel® 25 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males, 20 to 45 years of age the moment of screening
- •Body mass index is between 18.0 and 30.0 kg/m
排除标准
- •The tuberculosis patient or latent tuberculosis patient
- •Hypersensitivity response to the test and comparator drugs
研究组 & 干预措施
Group 1
Experimental
干预措施: LBEC0101 (Drug)
Group 2
Experimental
干预措施: Enbrel (Drug)
结局指标
主要结局
Etanercept levels in blood
时间窗: 22 day
次要结局
未报告次要终点
研究者
研究点 (1)
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