A Phase I, Single-centre, Randomized, Double-Blind, Two Treatment, Two-Period, Two-sequence, Two-way Crossover Study to Demonstrate Equivalence of Pharmacokinetic and Pharmacodynamic Characteristics and to Compare Safety and Tolerability of Granulocyte Colony Stimulating Factor (BioGenomics Limited) and Neupogen Administered via Subcutaneous Route as Multiple Consecutive Doses in Healthy Adult Human Volunteers

Trial Profile

A Phase I, Single-centre, Randomized, Double-Blind, Two Treatment, Two-Period, Two-sequence, Two-way Crossover Study to Demonstrate Equivalence of Pharmacokinetic and Pharmacodynamic Characteristics and to Compare Safety and Tolerability of Granulocyte Colony Stimulating Factor (BioGenomics Limited) and Neupogen Administered via Subcutaneous Route as Multiple Consecutive Doses in Healthy Adult Human Volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 03 Jan 2018

At a glance

  • Drugs Filgrastim (Primary)
  • Indications Neutropenia
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Biogenomics
  • Most Recent Events

    • 03 Jan 2018 New trial record
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