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 Laboratorios S/A, and Reference Formulation (Neulastim Injectable Solution Containing 6 mg) Marketed by Produtos Roche Quimicos e Farmaceuticos S/A

Trial Profile

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 Laboratorios S/A, and Reference Formulation (Neulastim Injectable Solution Containing 6 mg) Marketed by Produtos Roche Quimicos e Farmaceuticos S/A

Completed
Phase of Trial: Phase I

Latest Information Update: 09 Feb 2017

At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Neutropenia
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Eurofarma
  • Most Recent Events

    • 06 Feb 2017 Status changed to completed.
    • 19 Nov 2015 Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov.
    • 04 Nov 2015 New trial record
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