Evaluation of Pharmacokinetic/Pharmacodynamic Properties and Safety of Leucostim® Compared to Neupogen® in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Cmax of Filgrastim
研究概览
简要总结
A Randomized, Open-label, Two-way Crossover, Open-label Clinical Trial to Compare Pharmacokinetic/Pharmacodynamic Properties and Safety after Subcutaneous Administration of Leucostim® and Neupogen® in Healthy Adult Volunteers
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
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 19 - 45 years
- •BMI 18.5 - 25.0 kg/m2
- •Value of ANC(absolute neutrophil count) had to be inside the normality range at the screening
排除标准
- •Subjects with a history or presence of clinically relevant hypersensitivity reaction to investigational drugs (G-CSF) or their ingredients/additives
- •Subjects with a clinically relevant history of allergic reaction
- •Subjects with a history of acute infectious diseases within 2 weeks prior to administration of investigational products
- •At the investigator's discretion, subjects who is considered inappropriate to participate in the study due to any conditions including screening results
研究组 & 干预措施
Part 1; Filgrastim 5 ㎍/kg
Neupogen®(Filgrastim) 5 ㎍/kg or Leucostim®(Filgrastim) 5 ㎍/kg will be administered subcutaneously on Period 1, Day 1. And wash out for 28 days or more. Leucostim®(Filgrastim) 5 ㎍/kg or Neupogen®(Filgrastim) 5 ㎍/kg will be administered subcutaneously on Period 2, Day 1.
干预措施: Leucostim® (Drug)
Part 1; Filgrastim 5 ㎍/kg
Neupogen®(Filgrastim) 5 ㎍/kg or Leucostim®(Filgrastim) 5 ㎍/kg will be administered subcutaneously on Period 1, Day 1. And wash out for 28 days or more. Leucostim®(Filgrastim) 5 ㎍/kg or Neupogen®(Filgrastim) 5 ㎍/kg will be administered subcutaneously on Period 2, Day 1.
干预措施: Neupogen® (Drug)
Part 2; Filgrastim 10 ㎍/kg
Neupogen®(Filgrastim) 10 ㎍/kg or Leucostim®(Filgrastim) 10 ㎍/kg will be administered subcutaneously on Period 1, Day 1. And wash out for 28 days or more. Leucostim®(Filgrastim) 10 ㎍/kg or Neupogen®(Filgrastim) 10 ㎍/kg will be administered subcutaneously on Period 2, Day 1.
干预措施: Leucostim® (Drug)
Part 2; Filgrastim 10 ㎍/kg
Neupogen®(Filgrastim) 10 ㎍/kg or Leucostim®(Filgrastim) 10 ㎍/kg will be administered subcutaneously on Period 1, Day 1. And wash out for 28 days or more. Leucostim®(Filgrastim) 10 ㎍/kg or Neupogen®(Filgrastim) 10 ㎍/kg will be administered subcutaneously on Period 2, Day 1.
干预措施: Neupogen® (Drug)
结局指标
主要结局
Cmax of Filgrastim
时间窗: 0~48 hr
PK parameter
AUCinf of Filgrastim
时间窗: 0~48 hr
PK parameter
AUEC0-t of ANC(absolute neutrophil count)
时间窗: 0~120 hr
PD parameter
Emax of ANC(absolute neutrophil count)
时间窗: 0~120 hr
PD parameter
次要结局
- Tmax of Filgrastim(0~48 hr)
- AUC0-t of Filgrastim(0~48 hr)
- CL/F of Filgrastim(0~48 hr)
- AUEC0-t of CD34+ cell count(0~312 hr)
- Emax of CD34+ cell count(0~312 hr)
- Vd/F of Filgrastim(0~48 hr)