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

PHASE1CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 3, 2004

Primary Completion Date

February 28, 2005

Study Completion Date

February 28, 2005

Conditions
Parkinson Disease
Interventions
DRUG

Placebo oral capsule

Matching placebo capsules. Oral administration.

DRUG

Sinemet® 100/25

Single-dose of immediate release levodopa/carbidopa 100/25 mg consisted of 1 tablet of Sinemet® 100/25. Route of administration: Oral.

DRUG

Comtan®

Single-dose of entacapone 200 mg consisted of 1 tablet of Comtan®. Route of administration: Oral.

DRUG

BIA 6-512 25 mg

BIA 6-512 capsules strengths 25 mg. Oral administration.

DRUG

BIA 6-512 100 mg

BIA 6-512 capsules strengths 100 mg. Oral administration.

Trial Locations (1)

4745-457

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

All Listed Sponsors
lead

Bial - Portela C S.A.

INDUSTRY

NCT03091868 - Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics | Biotech Hunter | Biotech Hunter