Clinical Trial: Pharmacokinetics and Pharmacodynamics Comparison Study Between Two Pegfilgrastim Formulations

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Vo

Brief Summary:

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.


Detailed Summary:
Sponsor: Eurofarma Laboratorios S.A.

Current Primary Outcome:

  • Evaluation of comparative pharmacokinetics of pegfilgrastim in healthy volunteers with parameter peak maximum concentration in plasma (Cmax). [ Time Frame: 16 days ]

    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%.

  • Evaluation of comparative pharmacokinetics of pegfilgrastim in healthy volunteers with parameter area under recombinant G-CSF concentration curve versus time (AUC 0-t). [ Time Frame: 16 days ]

    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%.

  • Evaluation of comparative pharmacodynamics of pegfilgrastim in healthy volunteers with parameters: absolute neutrophil count (ANC) versus time. [ Time Frame: 16 days ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluation of comparative pharmacodynamics of pegfilgrastim in healthy volunteers with CD34+ count versus time. [ Time Frame: 6 days ]

CD34+ count until 144 hours


Original Secondary Outcome: Same as current

Information By: Eurofarma Laboratorios S.A.

Dates:
Date Received: October 20, 2015
Date Started: November 2015
Date Completion:
Last Updated: February 6, 2017
Last Verified: November 2016