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An assessor blind, randomized, 2-way crossover, two period, single-dose, phase I, active controlled, pharmacokinetic and pharmacodynamic study comparing pegfilgrastim biosimilar with Neulasta® of Amgen (US licensed product) in healthy adult human subjects.

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Trial Profile

An assessor blind, randomized, 2-way crossover, two period, single-dose, phase I, active controlled, pharmacokinetic and pharmacodynamic study comparing pegfilgrastim biosimilar with Neulasta® of Amgen (US licensed product) in healthy adult human subjects.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 03 Aug 2018

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At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Neutropenia
  • Focus Pharmacodynamics; Pharmacokinetics

    • Most Recent Events

    • 27 Jul 2018 According to Accord Healthcare media release, The CHMP positive opinion was based on Pelgraz's substantial clinical development programme, which supported its biosimilarity with Neulasta through a Phase I, randomised, assessor-blinded PK/PD study in healthy volunteers, and a Phase III study of patients with breast cancer (stage IIa, IIb, or IIIa) on TAC (docetaxel, doxorubicin, cyclophosphamide).
    • 14 Nov 2016 New trial record

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