Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Filgrastim (G-CSF)Produced by Blausiegel Indústria e Comércio Ltda. Compared to Granulokine Produced by Produtos Roche Químicos e Farmacêuticos S/A.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- The primary efficacy parameters will be based on the investigation of pharmacokinetics and pharmacodynamics of filgrastim in research subjects after administration of single dose via sc or iv routes at doses of 5 or 10 mcg/kg of the drug.
研究概览
简要总结
The primary aim of this study is to compare the pharmacokinetic and pharmacodynamic effects of two commercial preparations of filgrastim (T and C), after single dose via subcutaneous or intravenous administration at a concentration of 5 mcg/kg or 10 mcg/kg in healthy subjects through the alteration in the pharmacokinetic and pharmacodynamic parameters (measurement of serum levels of G-CSF and absolute neutrophil count - ANC).
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agree with all study procedures, sign and date back by their own free will, the IC;
- •Be between 18 and 50 years, of both sexes;
- •Present a body mass index (BMI) greater than or equal to 20 and less than or equal to 28;
- •are considered healthy, clinical, psychological and laboratory;
- •are female, but they have and maintain a safe method of contraception during the study.
排除标准
- •Known hypersensitivity to filgrastim;
- •Hypersensitivity to products derived from E. coli;
- •fever or infectious disease in the 07 days preceding the first administration;
- •Positive serology for hepatitis B or C and HIV;
- •Prior treatment with CSFs, interleukins and interferons;
- •Participation in a clinical study in the last 12 months;
- •Donation or loss of blood in the 03 months preceding the study;
- •General anesthesia in the 03 months preceding the study;
- •Provide a history of alcohol abuse, drug or drugs;
- •Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological, psoriasis, gout, acute myocardial infarction, thyroid or psychiatric disease;
- •Pregnant or lactating women.
研究组 & 干预措施
Group D 10 i.v.
Two periods, crossover, single dose, i.v., 10 mcg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.
干预措施: Filgrastim (Drug)
Group C 5 i.v.
Two periods, crossover, single dose, i.v., 5 mcg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.
干预措施: Filgrastim (Drug)
Group B 10 s.c.
Two periods, crossover, single dose, s.c., 10 mcg/kg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.
干预措施: Filgrastim (Drug)
Group A 5 s.c.
Two periods, crossover, single dose, s.c., 5 mcg, Comparator (n=16) x Test (n=16) in the first period and Test (n=16) x Comparator (n=16) in the second period, in a crossover basis.
干预措施: Filgrastim (Drug)
结局指标
主要结局
The primary efficacy parameters will be based on the investigation of pharmacokinetics and pharmacodynamics of filgrastim in research subjects after administration of single dose via sc or iv routes at doses of 5 or 10 mcg/kg of the drug.
时间窗: • PK.: 0, 15 min., 30 min., 45 min., 1h, 1h e 30min., 2h, 3h, 4h, 6h, 8h,10h, 12h, 16h, 24h and 48h. • PD (ANC): 0, 30 min., 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 32h, 48h, 72h, 96h and 120h
次要结局
未报告次要终点