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Bioequivalence of Nitisinone 10 mg Formulations vs Orfadin in Healthy Volunteers
NCT02750709Phase 1Completed
- Sponsor
- Cycle Pharmaceuticals
- Start
- Oct 2015
- Primary completion
- Dec 2015
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, open-label trial of nitisinone in hereditary tyrosinemia type 1 (HT1) (6 arms), sponsored by Cycle Pharmaceuticals. Primary endpoints: Maximum Observed Plasma Concentration and Area Under the Plasma Concentration Versus Time Curve (0-120h). Started Oct 2015; status: completed.
02
Drugs
nitisinone
03
Conditions
hereditary tyrosinemia type 1 (HT1)
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