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Multi-center, randomized, double-blind, crossover study in healthy volunteers comparing pharmacokinetics and pharmacodynamics of pegfilgrastim biosimilar with EU and US reference pegfilgrastim

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Trial Profile

Multi-center, randomized, double-blind, crossover study in healthy volunteers comparing pharmacokinetics and pharmacodynamics of pegfilgrastim biosimilar with EU and US reference pegfilgrastim

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 20 Jan 2020

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At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Febrile neutropenia
  • Focus Pharmacodynamics; Pharmacokinetics; Registrational

    • Most Recent Events

    • 14 Dec 2019 Results of meta-analysis of three phase I studies ( three arm parallel-group, two-way crossover and three-way crossover) presented at the 42nd Annual San Antonio Breast Cancer Symposium
    • 05 Nov 2019 According to a Sandoz media release, based on the data from this trial, Ziextenzo has been approved by the U.S. FDA and is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
    • 03 Apr 2019 According to a Novartis media release, Sandoz has resubmitted a Biologics License Application (BLA) for a proposed biosimilar pegfilgrastim to the US Food and Drug Administration (FDA) to address an FDA complete response letter received in June 2016. The resubmission includes new data from this study.

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