drugset / Trial / NCT04113772
Bio Equivalency 20 Mgm Orfadin and 20 Mgm of Nitisonine
RandomizedCrossoverSingle-blindTreatment
Summary
he purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product are bioequivalent to the reference product Orfadin 10 mg
Timeline
- Start
- 2019-11-01
- Primary completion
- 2020-12-31
- Completion
- 2021-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nitisinone | Small molecule | 0.5 mg/kg | — |