NCT02486432

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

A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) Doses Administered Using a Divided Dose Approach

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: NeuroDerm Ltd. · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) Doses Administered Using a Divided Dose Approach

Detailed description

This is a single centre, open-label, single period study in healthy subjects. Each subject will receive the following regimen: On Day -2, 10 mg domperidone administered every 8 hours 3 times a day (for illustrative purposes, dosing at 07:30, 15:30 and 23:30) On Day -1, 3 doses of 100 mg Sinemet® (every 8 hours) administered as 2 × Sinemet® 12.5 mg/50 mg tablets containing 13.5 mg carbidopa (equivalent to 12.5 mg anhydrous carbidopa) and 50 mg levodopa. Subjects will receive concomitant 10 mg domperidone 30 minutes before every Sinemet® dose. On Day 1, Sinemet® 12.5 mg/50 mg containing 13.5 mg carbidopa (equivalent to 12.5 mg of anhydrous carbidopa) and 50 mg levodopa administered every hour for 16 consecutive doses (total dose of 800 mg). Subjects will also receive concomitant domperidone up to 20 mg 30 minutes before the first Sinemet® 50 mg dose and every 8 hours (total of 3 doses) after treatment initiation. It is planned to enrol 6 subjects to ensure there are 6 evaluable subjects. A subject is considered to be evaluable if they have received all 16 Sinemet® 50 mg doses.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2015-07-01
• Last updated: 2015-07-01