At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Center, Single-Dose, Open-Label, Laboratory-Blind, Randomized, Three-Period Crossover Study to Determine the Bioequivalence of Two Oral Formulations Containing of Nitisinone 10 mg Compared to the Reference Formulation Orfadin 10 mg in at Least 18 Healthy Male and Female Subjects Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Nitisinone, Nitisinone 10 mg Tablet High Compritol, and 1 other intervention for Hereditary Tyrosinemia, Type I. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1 (TP1)) and Nitisinone 10 mg Tablets High Compritol (Test Product 2 (TP2)) are bioequivalent to the reference product Orfadin 10 mg capsules.
Study Details
Timeline
Interventions
A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state.