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A Phase I, Single Centre, Randomised, Interventional, Open-Label, Cross-Over Study to Evaluate the Pharmacokinetics (PK) and the Safety and Tolerability of a Total Daily Dose of 900mg of TETA 4HCL, Comparing a New Once Daily TETA 4HCL Formulation (300mg) (3x300mg Trientine Base Tablets, OD) With the Current Marketed Cuprior Formulation (150mg) (3x150mg Trientine Base Tablets, BD) in Adult Healthy Male and Female Participants

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Trial Profile

A Phase I, Single Centre, Randomised, Interventional, Open-Label, Cross-Over Study to Evaluate the Pharmacokinetics (PK) and the Safety and Tolerability of a Total Daily Dose of 900mg of TETA 4HCL, Comparing a New Once Daily TETA 4HCL Formulation (300mg) (3x300mg Trientine Base Tablets, OD) With the Current Marketed Cuprior Formulation (150mg) (3x150mg Trientine Base Tablets, BD) in Adult Healthy Male and Female Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 08 Jul 2024

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At a glance

  • Drugs Trientine (Primary)
  • Indications Hepatolenticular degeneration
  • Focus Pharmacokinetics
  • Sponsors Orphalan
  • Most Recent Events

    • 27 Feb 2024 Status changed from recruiting to completed.
    • 29 Jan 2024 Planned End Date changed from 29 Mar 2024 to 24 May 2024.
    • 29 Jan 2024 Planned primary completion date changed from 28 Jan 2024 to 13 Feb 2024.

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