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A Randomized, Double-blind, Crossover Study to Compare the Pharmacokinetic and Pharmacodynamic Bioequivalence of a Single Injection of MSB11455 and Neulasta in Healthy Adult Subjects

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Trial Profile

A Randomized, Double-blind, Crossover Study to Compare the Pharmacokinetic and Pharmacodynamic Bioequivalence of a Single Injection of MSB11455 and Neulasta in Healthy Adult Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Sep 2022

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At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Cancer
  • Focus Pharmacokinetics; Registrational
  • Sponsors Merck KGaA

    • Most Recent Events

    • 06 Sep 2022 According to a Fresenius Kabi media release, the United States (U.S.) Food and Drug Administration (FDA) has approved Stimufend (pegfilgrastim-fpgk), for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
    • 30 Mar 2022 According to a Fresenius Kabi media release, company announced that the European Commission granted marketing authorization for Stimufend.
    • 10 Jul 2020 Interim Results published in the Clinical Therapeutics

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