NCT03091543View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

May 4, 2004

Primary Completion Date

July 23, 2004

Study Completion Date

July 23, 2004

Conditions

Parkinson Disease

Interventions

DRUG

Madopar® HBS 125

1 capsule of Madopar® HBS 125 (levodopa 100 mg / benserazide 25 mg) in an open label manner, concomitantly with BIA 6-512/Placebo.

DRUG

Placebo

2 capsules of placebo

DRUG

BIA 6-512 25 mg dose

1 capsule of 25 mg plus 1 capsule of placebo

DRUG

BIA 6-512 50 mg dose

2 capsules of 25 mg

DRUG

BIA 6-512 100 mg dose

1 capsule of 100 mg plus 1 capsule of placebo

DRUG

BIA 6-512 200 mg dose

2 capsules of 100 mg

Trial Locations (1)

4745-457

Human Pharmacology Unit (UFH), S. Mamede Do Coronado

All Listed Sponsors

lead

Bial - Portela C S.A.

INDUSTRY

NCT03091543 - Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics | Biotech Hunter | Biotech Hunter