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
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 27 Apr 2016
Price :
$35
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At a glance
- Drugs Nitisinone (Primary)
- Indications Parkinson's disease; Tyrosinaemia type I
- Focus Pharmacokinetics
- Sponsors Swedish Orphan Biovitrum
- 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