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A randomized, double-blind, 2-treatment, 2-period, crossover phase I study to compare the pharmacokinetics, safety and tolerability of 60 IU/kg of Abcertin, and EU-sourced Cerezyme in healthy volunteers following a single intravenous administration.

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Trial Profile

A randomized, double-blind, 2-treatment, 2-period, crossover phase I study to compare the pharmacokinetics, safety and tolerability of 60 IU/kg of Abcertin, and EU-sourced Cerezyme in healthy volunteers following a single intravenous administration.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Apr 2021

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At a glance

  • Drugs Imiglucerase (Primary)
  • Indications Gaucher's disease
  • Focus Pharmacokinetics
  • Sponsors ISU Abxis

Most Recent Events

  • 20 Sep 2020 Status changed from not yet recruiting to completed.
  • 15 Oct 2019 New trial record

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