Bioequivalence Study of Two Oral Nitisinone Formulations to Treat Hereditary Tyrosinemia (HT-1)

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2016
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.
Epistemonikos ID: 4bee56b813e2e7980a3a1c29ae3cf2e2ec42df6e
First added on: May 13, 2024