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A Randomized, Open-label, Two-way Crossover, Single-Dose Clinical Trial to Compare Pharmacokinetic/Pharmacodynamic Properties and Safety after Subcutaneous Administration of Leucostim and Neupogen in Healthy Adult Volunteers

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A Randomized, Open-label, Two-way Crossover, Single-Dose Clinical Trial to Compare Pharmacokinetic/Pharmacodynamic Properties and Safety after Subcutaneous Administration of Leucostim and Neupogen in Healthy Adult Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Filgrastim (Primary)
  • Indications Diabetic neuropathies; Neutropenia
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Dong-A ST

    • Most Recent Events

    • 24 Mar 2018 Primary endpoint (Emax of ANC(absolute neutrophil count): Part I and Part II) has been met, according to results presented at the 119th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
    • 24 Mar 2018 Primary endpoint (AUEC0-120h of ANC(absolute neutrophil count):Part I and Part II) has been met, according to results presented at the 119th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
    • 24 Mar 2018 Primary endpoint (Cmax of Filgrastim: Part I and Part II) has been met, according to results presented at the 119th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.

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