Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- AUC0-∞
研究概览
简要总结
Pharmacokinetic/Pharmacodynamic Study of 3 Epoetin Alfa Formulations in Single Subcutaneous Doses Administered to Healthy Volunteers
SPONSOR Biosidus S.A.
详细描述
TITLE
Pharmacokinetic/ Pharmacodynamic Study of 3 Epoetin Alfa Formulations in Single Subcutaneous Doses Administered to Healthy Volunteers
SPONSOR
Biosidus S.A.
PRINCIPAL INVESTIGATOR
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Hemax® PFS 40,000 UI
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
干预措施: Epoetin Alfa 40000 UNT/ML (Drug)
Hemax® 40,000 UI
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
干预措施: Epoetin Alfa 40000 UNT/ML (Drug)
Erypo ® 40,000 UI
Epoetin Alfa 40000 UNT/ML subcutaneous single dose
干预措施: Epoetin Alfa 40000 UNT/ML (Drug)
结局指标
主要结局
AUC0-∞
时间窗: 120hr
AUC0-∞: Area under the serum concentration curve resulting from extrapolation from time 0 to time ∞.
Cmax
时间窗: 120hr
Cmax: maximum serum concentration of epoetin alfa.
AUC0-t
时间窗: 120 h
AUC0-t: Area under the serum concentration curve from time 0 to time t (in this case, 120 hours).
Tmax
时间窗: 120hr
Tmax: time to the maximum serum concentration of epoetin alfa
次要结局
- ADAs(120hr)
- Reticulocyte Response: Cmax(120hr)
- Reticulocyte Response: AUC 0-120h(120hr)
- Adverse Events(120hr)