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A multicentre, randomized double blind, single dose, 3-treatment, 6-sequence crossover phase 1 study of Sandoz proposed biosimilar, US reference, and EU reference pegfilgrastim demonstrating similarity in PK, PD, safety and immunogenecity in healthy volunteers

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A multicentre, randomized double blind, single dose, 3-treatment, 6-sequence crossover phase 1 study of Sandoz proposed biosimilar, US reference, and EU reference pegfilgrastim demonstrating similarity in PK, PD, safety and immunogenecity in healthy volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Feb 2020

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At a glance

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

    • Most Recent Events

    • 05 Feb 2020 Primary endpoint (Pharmacodynamic parameters) has been met, as per Results published in the British Journal of Clinical Pharmacology
    • 05 Feb 2020 Primary endpoint (Pharmacokinetic parameters) has been met, as per Results published in the British Journal of Clinical Pharmacology
    • 05 Feb 2020 Results published in the British Journal of Clinical Pharmacology

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