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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
100
Unidade Integrada de Farmacologia e Gastroenterologia
Bragança Paulista, São Paulo, Brazil
Evaluation of comparative pharmacokinetics of pegfilgrastim in healthy volunteers with parameter peak maximum concentration in plasma (Cmax).
A 90% confidence interval (CI) for the differences in transformed data means of test and comparator drugs, for Cmax. The CI antilog obtained constitutes the 90% CI for the ratio of geometric averages of the parameter: (Cmax test / Cmax comparator) Formulations are considered statistically bioequivalent if these intervals are between limits of 80% and 125%.
Time frame: 16 days
Evaluation of comparative pharmacokinetics of pegfilgrastim in healthy volunteers with parameter area under recombinant G-CSF concentration curve versus time (AUC 0-t).
A 90% confidence interval (CI) for the differences in transformed data means of test and comparator drugs, for AUC 0-t. The CI antilog obtained constitutes the 90% CI for the ratio of geometric averages of the parameter: (AUC0-t test / AUC0-t comparator) Formulations are considered statistically bioequivalent if these intervals are between limits of 80% and 125%.
Time frame: 16 days
Evaluation of comparative pharmacodynamics of pegfilgrastim in healthy volunteers with parameters: absolute neutrophil count (ANC) versus time.
Time frame: 16 days
Evaluation of comparative pharmacodynamics of pegfilgrastim in healthy volunteers with CD34+ count versus time.
CD34+ count until 144 hours
Time frame: 6 days
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