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 ]
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