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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.

NCT01549301 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2018-06-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Azidus Brasil

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-08-31
Completion
2013-09-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01549301 on ClinicalTrials.gov