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Hereditary Tyrosinemia, Type I clinical trials

View clinical trials related to Hereditary Tyrosinemia, Type I.

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NCT ID: NCT02750709 Completed - Clinical trials for Hereditary Tyrosinemia, Type I

Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin

Start date: October 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1) and Nitisinone 10 mg Tablets High Compritol (Test Product 2) are bioequivalent to the reference product Orfadin 10 mg capsules.

NCT ID: NCT02750345 Completed - Clinical trials for Hereditary Tyrosinemia, Type I

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

Start date: March 2016
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT02750332 Completed - Clinical trials for Hereditary Tyrosinemia, Type I

Bioavailability Food-Effect Study of an Oral Nitisinone Formulation to Treat Hereditary Tyrosinemia (HT-1)

Start date: November 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the bioavailability of the Test Product, Nitisinone 10 mg Tablet, under fasting and fed conditions (food-effect).

NCT ID: NCT02323529 Completed - Clinical trials for Hereditary Tyrosinemia, Type I

Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1

HT-1
Start date: December 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to look at the steady-state serum concentrations of nitisinone when switching from twice daily and once daily dosing.

NCT ID: NCT02320084 Completed - Clinical trials for Hereditary Tyrosinemia, Type I

Long Term Safety Study of Orfadin Treatment in HT-1 Patients in Standard Clinical Care

OPAL
Start date: September 2013
Phase:
Study type: Observational

The purpose of this study is to look at the long term safety profile of Orfadin treatment in patients suffering from hereditary tyrosinemia type 1 (HT-1). Patients included in the study will use Orfadin according to normal clinical practice.

NCT ID: NCT01734889 Completed - Clinical trials for Hereditary Tyrosinemia, Type I

Taste and Palatability of Orfadin Suspension

Start date: October 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to verify that pediatric patients, especially those who are not old enough to swallow capsules, accept the taste and palatability of a new suspension.