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
6	パーキンソン病	2

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	NCT03091868 (ClinicalTrials.gov)	November 3, 2004	21/3/2017	Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics	A Double-blind, Randomised, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability and Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Carbidopa 100/25 mg or With a Single-dose of Levodopa/Carbidopa 100/25 mg Plus a Single-dose of Entacapone 200 mg	Parkinson Disease	Drug: Placebo oral capsule;Drug: Sinemet® 100/25;Drug: Comtan®;Drug: BIA 6-512 25 mg;Drug: BIA 6-512 100 mg	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	80	Phase 1	Portugal
2	NCT03091543 (ClinicalTrials.gov)	May 4, 2004	21/3/2017	Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics	A Double-blind, Randomised, Crossover, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 100/25 mg	Parkinson Disease	Drug: Madopar® HBS 125;Drug: Placebo;Drug: BIA 6-512 25 mg dose;Drug: BIA 6-512 50 mg dose;Drug: BIA 6-512 100 mg dose;Drug: BIA 6-512 200 mg dose	Bial - Portela C S.A.	NULL	Completed	18 Years	45 Years	All	20	Phase 1	Portugal

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

NCT03091868
(ClinicalTrials.gov)

November 3, 2004

21/3/2017

Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics

A Double-blind, Randomised, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability and Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Carbidopa 100/25 mg or With a Single-dose of Levodopa/Carbidopa 100/25 mg Plus a Single-dose of Entacapone 200 mg

Parkinson Disease

Drug: Placebo oral capsule;Drug: Sinemet® 100/25;Drug: Comtan®;Drug: BIA 6-512 25 mg;Drug: BIA 6-512 100 mg

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

All

Phase 1

Portugal

NCT03091543
(ClinicalTrials.gov)

May 4, 2004

21/3/2017

Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics

A Double-blind, Randomised, Crossover, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 100/25 mg

Parkinson Disease

Drug: Madopar® HBS 125;Drug: Placebo;Drug: BIA 6-512 25 mg dose;Drug: BIA 6-512 50 mg dose;Drug: BIA 6-512 100 mg dose;Drug: BIA 6-512 200 mg dose

Bial - Portela C S.A.

NULL

Completed

18 Years

45 Years

All

Phase 1

Portugal