NCT02589301

Pharmacokinetics and Pharmacodynamics Comparison Study Between Two Pegfilgrastim Formulations

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Neutropenia
• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Pegfilgrastim

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-03-01
• Completion: 2016-11-01
• First posted: 2015-10-28
• Last updated: 2017-02-07

Locations

1 site across 1 country: Brazil