Healthy Clinical Trial
Official title:
A Single-center, Open-label, Parallel Study With Single Subcutaneous Injection for Pharmacokinetics and Pharmacodynamics Comparison of Two Pegfilgrastim Formulations in Both Male and Female Healthy Volunteers, Test Formulation is an Injectable Solution Containing 6 mg of Pegfilgrastim, Manufactured by Eurofarma Laboratórios S/A, and Reference Formulation (Neulastim® Injectable Solution Containing 6 mg) Marketed by Produtos Roche Químicos e Farmacêuticos S/A
This study will evaluate the pharmacokinetics (relative bioavailability) and
pharmacodynamics, after single subcutaneous application, in healthy volunteers of both
sexes, between pegfilgrastim formulation, produced by Eurofarma Laboratorios S/A and
Neulastim® (reference formulation), marketed by Produtos Roche Químicos e Farmacêuticos S/A.
In addition to that, a pharmacodynamics comparison will be performed, through change in
absolute neutrophil count in leukogram performed in the same time of pharmacokinetics
analysis collection and through CD34+ cell count in peripheral blood at timepoints 0:00,
96:00 and 384:00 hours.
n/a
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