drugset / Trial / NCT01549301
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.
RandomizedCrossoverOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2012-08
- Primary completion
- 2013-08
- Completion
- 2013-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Subject | filgrastim | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |
Indications
No indication recorded.