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
Phase of Trial: Phase I
Latest Information Update: 09 Feb 2017
At a glance
- Drugs Pegfilgrastim (Primary)
- Indications Neutropenia
- Focus Pharmacodynamics; Pharmacokinetics
- Sponsors Eurofarma
- 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