8 completed. 8 Phase 1, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 8 | Completed 8 |
| Phase 2 | 1 | Completed 1 |
Follow nitisinone: new trials by email Literature Review of nitisinone trials Research Report on nitisinone
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Investigate the Potential Influence of Nitisinone on the Metabolism and the Transport of Other Drugs in Healthy Volunteers Nitisinone in Arm A, Tolbutamide, Metoprolol - Drug Drug Interaction | Phase 1 | Completed | Swedish Orphan Biovitrum | 36 | 2017-03-28 | 2017-08-10 |
| Bioequivalence Study of Two Oral Nitisinone Formulations to Treat Hereditary Tyrosinemia (HT-1) Nitisinone, Nitisinone Baked Tablet, Orfadin - Hereditary Tyrosinemia, Type I | Phase 1 | Completed | Cycle Pharmaceuticals Ltd. | 24 | 2016-03-01 | 2017-06-14 |
| Bioavailability Food-Effect Study of an Oral Nitisinone Formulation to Treat Hereditary Tyrosinemia (HT-1) Nitisinone - Hereditary Tyrosinemia, Type I | Phase 1 | Completed | Cycle Pharmaceuticals Ltd. | 20 | 2015-11-01 | 2017-03-15 |
| Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin Nitisinone, Nitisinone 10 mg Tablet High Compritol, Orfadin - Hereditary Tyrosinemia, Type I | Phase 1 | Completed | Cycle Pharmaceuticals Ltd. | 24 | 2015-10-01 | 2017-03-15 |
| Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules. Nitisinone 20 mg, Nitisinone 10 mg - Healthy | Phase 1 | Completed | Swedish Orphan Biovitrum | 12 | 2013-05-01 | 2021-10-12 |
| Nitisinone for Type 1B Oculocutaneous Albinism Nitisinone - Albinism, Vision Loss | Phase 1 / Phase 2 | Completed | National Eye Institute (NEI) | 5 | 2013-04-16 | 2019-02-26 |
| Taste and Palatability of Orfadin Suspension Nitisinone - Hereditary Tyrosinemia, Type I | Phase 1 | Completed | Swedish Orphan Biovitrum | 18 | 2012-10-01 | 2014-11-06 |
| Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension Nitisinone, capsule, Nitisinone, suspension - Healthy Volunteers | Phase 1 | Completed | Swedish Orphan Biovitrum | 12 | 2012-08-01 | 2014-03-17 |
Tyrosinemias (4) · Albinism (1) · Vision Disorders (1)
Swedish Orphan Biovitrum (4) · Cycle Pharmaceuticals Ltd. (3) · National Eye Institute (NEI) (1)
South Africa (3) · Germany (2) · Netherlands (2) · France (1) · United Kingdom (1) · United States (1)
Erik Brouwer, MD (3) · Brian P Brooks, M.D. (1)
2016 (1)