Bioequivalence Study of Two Oral Nitisinone Formulations to Treat Hereditary Tyrosinemia (HT-1)
Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1)
and Nitisinone 10 mg Tablets 'Baked' for 6 months @ 40°C/75% RH (Test Product 2) are
bioequivalent to the reference product Orfadin 10 mg hard capsules.