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Pharmacokinetics and Pharmacodynamics Comparison Study Between Two Pegfilgrastim Formulations

NCT02589301 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-02-07

No results posted yet for this study

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

Interventions

BIOLOGICAL

Pegfilgrastim

Sponsors & Collaborators

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Principal Investigators

  • José Pedrazzoli Junior · Unidade Integrada de Farmacologia e Gastroenterologia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-03-31
Completion
2016-11-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02589301 on ClinicalTrials.gov