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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Azidus Brasil · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Filgrastim	filgrastim, single dose, s.c., dosage: 5 mcg/kg
DRUG	Filgrastim	filgrastim, single dose, s.c., dosage: 10 mcg/kg
DRUG	Filgrastim	Filgrastim, i.v., single dose, dosage: 5 mcg/kg
DRUG	Filgrastim	Filgrastim, i.v., single dose, dosage: 10 mcg/kg

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2012-03-09
• Last updated: 2018-06-20

Locations

1 site across 1 country: Brazil