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A study of bioequivalence between HD201 and trastuzumab sourced in the European Union (EU-trastuzumab)

Trial Profile

A study of bioequivalence between HD201 and trastuzumab sourced in the European Union (EU-trastuzumab)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 31 May 2019

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At a glance

  • Drugs Trastuzumab (Primary)
  • Indications Breast cancer; Gastric cancer; Oesophageal cancer
  • Focus First in man; Pharmacokinetics
  • Most Recent Events

    • 31 May 2019 Results assessing analytical biocomparability physiochemical and biological properties between HD201 and EU and US-Herceptin in terms published in conjunction with 55th Annual Meeting of the American Society of Clinical Oncology (2019)
    • 08 Mar 2018 New trial record
    • 01 Mar 2018 Primary endpoint (AUC0-infinity) has been met as per the results published in the Clinical Therapeutics.
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