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A Phase I, Double-Blind, Randomised, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin and US-Herceptin in Healthy Male Subjects

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Trial Profile

A Phase I, Double-Blind, Randomised, Parallel Group Study to Demonstrate the Equivalent Pharmacokinetic Properties of a Single Intravenous Dose of HD201 and EU-Herceptin and US-Herceptin in Healthy Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 02 Aug 2024

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At a glance

  • Drugs Trastuzumab (Primary)
  • Indications Breast cancer; Gastric cancer; Male breast cancer; Oesophageal cancer
  • Focus Pharmacokinetics
  • Acronyms TROIKA-1
  • Sponsors Prestige BioPharma

Most Recent Events

  • 01 Aug 2024 According to a Prestige BioPharma media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for Tuznue, a Herceptin (trastuzumab) biosimilar.
  • 21 Sep 2020 Results presented at the 45th European Society for Medical Oncology Congress
  • 31 May 2020 Results establishing analytical and clinical similarity between HD201 and Herceptin using 2 trials TROIKA and TROIKA I.presented at the 56th Annual Meeting of the American Society of Clinical Oncology

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