A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa)

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
Parkinson's Disease
Interventions
DRUG

Levodopa/Carbidopa (Sinemet)

Oral administration of 2 × 12.5 mg/50 mg Sinemet® tablet containing 13.5 mg carbidopa (equivalent to 12.5 mg anhydrous carbidopa) and 50 mg levodopa three times a day on Day -1 with 240 mL water Oral administration of 1 × 12.5 mg/50 mg Sinemet® tablets containing 13.5 mg carbidopa (equivalent to 12.5 mg of anhydrous carbidopa) and 50 mg levodopa administered with 100 mL water every hour for 16 hours on Day 1

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Quotient Clinical

OTHER

lead

NeuroDerm Ltd.

INDUSTRY

NCT02486432 - A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) | Biotech Hunter | Biotech Hunter