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An Open-label, Non-randomized, 2-arm, 2-period Fixed Sequence Phase 1 Study to Evaluate the Potential Inhibition of Nitisinone on Cytochrome P450 2C9, 2D6, and 2E1 and the Organic Anion Transporters OAT1 and OAT3 in Healthy Volunteers

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Trial Profile

An Open-label, Non-randomized, 2-arm, 2-period Fixed Sequence Phase 1 Study to Evaluate the Potential Inhibition of Nitisinone on Cytochrome P450 2C9, 2D6, and 2E1 and the Organic Anion Transporters OAT1 and OAT3 in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Nitisinone (Primary) ; Chlorzoxazone; Furosemide; Metoprolol; Tolbutamide
  • Indications Inborn error metabolic disorders; Tyrosinaemia type I
  • Focus Pharmacokinetics
  • Sponsors Swedish Orphan Biovitrum

Most Recent Events

  • 15 Nov 2018 Results asseesing pharmacokinetics, safety and tolerability of Nitisinone in healthy volunteers, published in the European Journal of Clinical Pharmacology.
  • 09 Aug 2017 Status changed from active, no longer recruiting to completed.
  • 21 Jul 2017 Planned End Date changed from 19 Jul 2017 to 25 Jul 2017.

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