Orfadin ( DrugBank: - )

2 diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
6	パーキンソン病	2
241	高チロシン血症1型	11

6. パーキンソン病

臨床試験数 : 2,307 / 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199

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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	EUCTR2009-013670-41-CZ (EUCTR)	18/11/2009	07/09/2009	A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Eff ...	A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Eff ...	Parkinson´s disease inadequately controlled on a stable regimen of anti-Parkinsonian medications. Me ...	Trade Name: Orfadin INN or Proposed INN: NITISINONE	Synosia Therapeutics AG	NULL	Not Recruiting			Female: yes Male: yes	126		Czech Republic;France
2	EUCTR2009-013670-41-FR (EUCTR)	16/10/2009	11/09/2009	A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Eff ...	A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Two-arm Safety and Eff ...	Parkinson´s disease inadequately controlled on a stable regimen of anti-Parkinsonian medications. Me ...	Trade Name: Orfadin INN or Proposed INN: NITISINONE	Synosia Therapeutics AG	NULL	Not Recruiting			Female: yes Male: yes	126	Phase 2	France;Czech Republic

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241. 高チロシン血症1型

臨床試験数 : 14 / 薬物数 : 7 - (DrugBank : 1) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 5

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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	NCT04113772 (ClinicalTrials.gov)	November 1, 2019	1/10/2019	Bio Equivalency 20 Mgm Orfadin and 20 Mgm of Nitisonine	Orfadin and Nitinosine Study	Hereditary Tyrosinemia, Type I	Drug: Nitisinone;Drug: Orfadin	Sutphin Drugs	NULL	Not yet recruiting	18 Years	50 Years	All	4	N/A	India
2	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 N ...	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
3	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 ...	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
4	EUCTR2013-004132-29-DK (EUCTR)	16/12/2014	25/08/2014	An open-label, non-randomized, sequential, multicenter study to evaluate the pharmacokinetics, effic ...	An open-label, non-randomized, sequential, multicenter study to evaluate the pharmacokinetics, effic ...	hereditary tyrosinemia type 1 MedDRA version: 17.1;Level: LLT;Classification code 10069462;Term: Tyr ...	Trade Name: Orfadin INN or Proposed INN: NITISINONE	Swedish Orphan Biovitrum AB (Publ)	NULL	Not Recruiting			Female: yes Male: yes	20		Belgium;Denmark;Sweden
5	NCT02323529 (ClinicalTrials.gov)	December 2014	18/12/2014	Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Nitisinone in HT-1	Open-label, Multicentre, Multiple-dose Trial to Evaluate Pharmacokinetics, Efficacy and Safety of On ...	Hereditary Tyrosinemia, Type I	Drug: Nitisinone	Swedish Orphan Biovitrum	NULL	Completed	N/A	N/A	Both	18	Phase 3	Belgium;Denmark;France;Germany;Sweden
6	EUCTR2013-004132-29-BE (EUCTR)	06/11/2014	15/10/2014	An open-label, non-randomized, sequential, multicenter study to evaluate the pharmacokinetics, effic ...	An open-label, non-randomized, sequential, multicenter study to evaluate the pharmacokinetics, effic ...	hereditary tyrosinemia type 1 MedDRA version: 17.0;Level: LLT;Classification code 10069462;Term: Tyr ...	Trade Name: Orfadin INN or Proposed INN: NITISINONE Trade Name: Orfadin INN or Proposed INN: NITISINONE ...	Swedish Orphan Biovitrum AB (Publ)	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 4	Belgium;Denmark;Sweden
7	EUCTR2013-004132-29-SE (EUCTR)	15/10/2014	18/08/2014	An open-label, non-randomized, sequential, multicenter study to evaluate the pharmacokinetics, effic ...	An open-label, non-randomized, sequential, multicenter study to evaluate the pharmacokinetics, effic ...	hereditary tyrosinemia type 1 MedDRA version: 17.1;Level: LLT;Classification code 10069462;Term: Tyr ...	Trade Name: Orfadin INN or Proposed INN: NITISINONE	Swedish Orphan Biovitrum AB (Publ)	NULL	Not Recruiting			Female: yes Male: yes	20		Belgium;Denmark;Sweden
8	NCT02320084 (ClinicalTrials.gov)	September 2013	23/10/2014	Long Term Safety Study of Orfadin Treatment in HT-1 Patients in Standard Clinical Care	A Non-interventional Post Authorization Study (PASS) to Evaluate Long-term Safety of OrfadinTreatmen ...	Hereditary Tyrosinemia, Type I	Drug: Nitisinone	Swedish Orphan Biovitrum	NULL	Completed	N/A	N/A	All	315		Austria;Belgium;Czechia;Denmark;Finland;France;Germany;Hungary;Ireland;Italy;Netherlands;Norway;Pola ...
9	EUCTR2012-002286-36-DE (EUCTR)	19/11/2012	03/08/2012	Taste and palatability of Orfadin suspension.	Taste and palatability of Orfadinsuspension. An open, non-controlled 3-day study in pediatric patien ...	Hereditary tyrosinemia type 1 (HT-1) MedDRA version: 14.1;Level: LLT;Classification code 10069459;Te ...	Product Name: Orfadin oral suspension 4mg/ml INN or Proposed INN: Nitisinone	Swedish Orphan Biovitrum AB	NULL	Not Recruiting			Female: yes Male: yes	18		Germany;United Kingdom
10	EUCTR2012-002286-36-GB (EUCTR)	04/10/2012	10/08/2012	Taste and palatability of Orfadin suspension.	Taste and palatability of Orfadinsuspension. An open, non-controlled 3-day study in pediatric patien ...	Hereditary tyrosinemia type 1 (HT-1) MedDRA version: 14.1;Level: LLT;Classification code 10069459;Te ...	Product Name: Orfadin oral suspension 4mg/ml INN or Proposed INN: NITISINONE	Swedish Orphan Biovitrum AB	NULL	Not Recruiting			Female: yes Male: yes	18		Germany;United Kingdom

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