A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced Parkinson's Disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott; AbbVie
• Collaborator: Quintiles, Inc.
• Treatments: Carbidopa; Carbidopa, levodopa drug combination; Levodopa

Criteria

Inclusion Criteria

1. Male or female subjects at least 30 years old;

2. Subjects with advanced Parkinson's disease who are already on LCIG (Duodopa®) for at least 30 days;

3. Body mass index range from 18.0 to 30.0 kg/m2

Exclusion Criteria

1. Subjects who are considered to be violent or subjects considered at suicidal risk by the investigator;

2. Clinically significant abnormal laboratory data at baseline or any abnormal laboratory value that could interfere with the study assessments;

3. Subjects with serious symptomatic cerebral disease, cerebrovascular disease, focal neurological lesions (previous brain surgery), any acute brain trauma requiring treatment with anticonvulsant therapy, or acute stroke