A Randomized, Open Label, Single Subcutaneous Dose, 2x2 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AUClast of somatropin
研究概览
简要总结
A randomized, Open Label, Single Subcutaneous Dose, 2x2 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
- None
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 adults aged 19 to 40years at screening.
- •Voluntarily decide to participate and provide written informed consent.
- •Able to receive the investigational product (IP) and pre-treatment drugs.
- •Wiliing and able to comply with study requirements, including follow-up visits and blood/urine sampling.
排除标准
- •History of conditions contraindicating somatropin or pre-treatment drugs.
- •Clinically significant medical history.
- •Participation in another clinical trial and receipt of an investigational product within 80 days prior to the first IP administration.
研究组 & 干预措施
Sequence 1
Participants receive a single subcutaneous dose of the Test Drug(T), in the first period, followed by a washout period, and then a single subcutaneous dose of the Reference Drug(R) in the second period.
干预措施: Test Drug (Eutropin Catridge, 48IU/Cartridge) (Drug)
Sequence 1
Participants receive a single subcutaneous dose of the Test Drug(T), in the first period, followed by a washout period, and then a single subcutaneous dose of the Reference Drug(R) in the second period.
干预措施: Reference Drug (Eutropin, 4 IU/vial) (Drug)
Sequence 2
Participants receive a single subcutaneous dose of the Reference Drug(R), in the first period, followed by a washout period, and then a single subcutaneous dose of the Test Drug(T) in the second period.
干预措施: Test Drug (Eutropin Catridge, 48IU/Cartridge) (Drug)
Sequence 2
Participants receive a single subcutaneous dose of the Reference Drug(R), in the first period, followed by a washout period, and then a single subcutaneous dose of the Test Drug(T) in the second period.
干预措施: Reference Drug (Eutropin, 4 IU/vial) (Drug)
结局指标
主要结局
AUClast of somatropin
时间窗: 0 to 24 hours post-dose
AUClast will be used to evaluate the pharmacokinetics of somatropin
次要结局
- AUCinf of somatropin(0 to 24 hours post-dose)
- Cmax of somatropin(0 to 24 hours post-dose)
- Tmax of soatropin(0 to 24 hours post-dose)
- T1/2β of somatropin(0 to 24 hours post-dose)
- Change in IGF-1 levels(0 to 24 hours post-dose)
- Change in IGFBP-3 levels(0 to 24 hours post-dose)