Sustained Release Oral Formulation for Treatment of Parkinson's Disease
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
Achieving sustained blood levels of carbidopa/levodopa has been a challenge in the treatment of PD and although levodopa remains the most commonly used drug, motor fluctuations remain a major disability especially in advanced Parkinson's disease. The aim of this study is to determine the efficacy of a novel oral carbidopa-levodopa formulation in achieving a sustained blood level of levodopa and carbidopa in normal volunteers.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• Normal healthy
• Are 18-65 years of age
• Are not currently taking medications regularly
• Able to fast 6 hours (water allowed)
Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Research Coordinator
umnstudies@gmail.com
507-339-4093
Time Frame
Start Date: 2025-06-12
Estimated Completion Date: 2026-06-16
Participants
Target number of participants: 6
Treatments
Experimental: levodopa/carbidopa oral formulation A
LD/CD will be delivered using an oral device placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption.
Experimental: levodopa/carbidopa oral formulation B
LD/CD will be delivered using an oral device placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption.
Related Therapeutic Areas
Sponsors
Leads: University of Minnesota