NCT04085224已完成1 期
A Randomized, Open Label, Single Subcutaneous Dose 6x3 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers
LG Chem1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年9月10日最近更新:
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
- 24
- 试验地点
- 1
- 主要终点
- Bioavailability
研究概览
简要总结
A Randomized, Open Label, Single Subcutaneous Dose 6x3 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability among Different Eutropin Formulations in Healthy Volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers between the ages of 19 or more and less than 40 years (19 =< age < 40) on the day of screening
- •Negative findings in serum / urine hCG test or Subjects who are not pregnant or lactating in women
排除标准
- •Administered other drug(s) in other clinical study within 180 days prior to the day of screening
研究组 & 干预措施
1
Active Comparator
干预措施: Somatropin (Drug)
3
Experimental
干预措施: Somatropin (Drug)
2
Experimental
干预措施: Somatropin (Drug)
结局指标
主要结局
Bioavailability
时间窗: 2years
次要结局
未报告次要终点
研究者
研究点 (1)
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