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

Trial Profile

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

Completed
Phase of Trial: Phase I

Latest Information Update: 24 Mar 2018

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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top