Clinical trial
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
NCT02589301 is registered in ClinicalTrials.gov with Eurofarma Laboratorios S.A. as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- 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 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
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Phase
- Phase 1
- Overall status
- Completed
- Start date
- November 30, 2015
- Completion date
- November 30, 2016
- Enrollment
- 100 (actual)
- Sites
- 1
Conditions
As the registry lists them; a condition with its own page is linked.
healthy, neutropenia