A Study to Evaluate the Bioequivalence of Orfadin Suspension 4 mg/mL Compared to Orfadin Capsules 10 mg, and the Effect of Food on the Bioavailability of the Suspension. An Open-label, Randomized, Cross-over, Single-dose Study in Healthy Volunteers

Trial Profile

A Study to Evaluate the Bioequivalence of Orfadin Suspension 4 mg/mL Compared to Orfadin Capsules 10 mg, and the Effect of Food on the Bioavailability of the Suspension. An Open-label, Randomized, Cross-over, Single-dose Study in Healthy Volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 26 Apr 2016

At a glance

  • Drugs Nitisinone (Primary)
  • Indications Parkinson's disease; Tyrosinaemia type I
  • Focus Pharmacokinetics
  • Sponsors Swedish Orphan Biovitrum
  • Most Recent Events

    • 26 Apr 2016 According to a Swedish Orphan Biovitrum media release, the US FDA has approved ORFADIN Oral Suspension for the treatment of Hereditary Tyrosinemia Type 1 (HT-1).
    • 29 Dec 2012 New trial record
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