NCT01044836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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Etanercept levels in blood
研究概览
简要总结
The purpose of this study is compare the safety and pharmacokinetic characteristics of HD203 with those of etanercept after subcutaneous injection in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- 未提供
结局指标
主要结局
Etanercept levels in blood
时间窗: 21 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety and Pharmacokinetic Characteristics of HD203 Liquid in Healthy Male VolunteersHealthyNCT01894412Hanwha Chemical48
已完成
1 期
Safety and Pharmacokinetic Characteristics of HD203 Liq. in Healthy SubjectsHealthyNCT01431404Hanwha Chemical44
已完成
1 期
A Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin® and US-Herceptin® in Healthy Male SubjectsHealthy VolunteersNCT03776240Prestige Biopharma Limited105
已完成
1 期
Pharmacokinetics of HD-P023 and Co-administration of Teneligliptin and Empagliflozin High in Healthy VolunteersHealthy VolunteersNCT06339788Handok Inc.40
终止
3 期
Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHDAttention Deficit Hyperactivity DisorderNCT06431256Ironshore Pharmaceuticals and Development, Inc26