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

Parkinson's Disease Clinical Trial

Official title: 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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

• NCT number: NCT02486432
• Study type: Interventional
• Source: NeuroDerm Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: April 2015
• Completion date: April 2015