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Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Two-Stage, Comparative Pharmacokinetic Study of EirGenix' Trastuzumab and Herceptin® (Trastuzumab) Sourced From US and EU Administered to Healthy Male Volunteers

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Trial Profile

Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Two-Stage, Comparative Pharmacokinetic Study of EirGenix' Trastuzumab and Herceptin® (Trastuzumab) Sourced From US and EU Administered to Healthy Male Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Oct 2023

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At a glance

  • Drugs Trastuzumab (Primary)
  • Indications Breast cancer
  • Focus Pharmacokinetics
  • Sponsors EirGenix

    • Most Recent Events

    • 03 Oct 2023 Primary endpoint (Area under the concentration/time curve, from time 0 h extrapolated to infinity (AUC(0-))) has been met, according to an European Medicines Agency.
    • 15 May 2017 New trial record
    • 02 May 2017 According to an EirGenix media release, the trial was performed in compliance with EMA and FDA biosimilar regulations.
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