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	NCT02750345 (ClinicalTrials.gov)	March 2016	21/4/2016	Bioequivalence Study of Two Oral Nitisinone Formulations to Treat Hereditary Tyrosinemia (HT-1)	A Three-Period Crossover Study to Determine the Bioequivalence of Two Oral Formulations Containing Nitisinone 10 mg Compared to Reference Formulation Orfadin In Healthy Subjects Under Fasting Conditions	Hereditary Tyrosinemia, Type I	Drug: Nitisinone;Drug: Nitisinone Baked Tablet;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

NCT02750345
(ClinicalTrials.gov)

March 2016

21/4/2016

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

A Three-Period Crossover Study to Determine the Bioequivalence of Two Oral Formulations Containing Nitisinone 10 mg Compared to Reference Formulation Orfadin In Healthy Subjects Under Fasting Conditions

Hereditary Tyrosinemia, Type I

Drug: Nitisinone;Drug: Nitisinone Baked Tablet;Drug: Orfadin

Cycle Pharmaceuticals Ltd.

Parexel

Completed

18 Years

55 Years

All

Phase 1

South Africa