DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
241	高チロシン血症1型	1

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02750709 (ClinicalTrials.gov)	October 2015	20/4/2016	Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin	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	Hereditary Tyrosinemia, Type I	Drug: Nitisinone;Drug: Nitisinone 10 mg Tablet High Compritol;Drug: Orfadin	Cycle Pharmaceuticals Ltd.	Parexel	Completed	18 Years	55 Years	All	24	Phase 1	South Africa

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02750709
(ClinicalTrials.gov)

October 2015

20/4/2016

Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin

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

Hereditary Tyrosinemia, Type I

Drug: Nitisinone;Drug: Nitisinone 10 mg Tablet High Compritol;Drug: Orfadin

Cycle Pharmaceuticals Ltd.

Parexel

Completed

18 Years

55 Years

All

Phase 1

South Africa