RecruitingEarly Phase 1NCT05471609

Sustained Release Oral Formulation for Treatment of Parkinson's Disease

Sponsor

University of Minnesota

Enrollment

6 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new slow-release (sustained release) oral pill formulation for a Parkinson's disease medication to see how healthy volunteers absorb and tolerate it compared to the standard formulation. **You may be eligible if...** - You are a generally healthy adult between 18 and 65 years old - You are not currently taking any medications regularly - You are able to fast for 6 hours before taking the study medication (water is allowed) **You may NOT be eligible if...** - You are pregnant - You have a condition or situation that prevents you from fasting as required Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGlevodopa/carbidopa oral formulation A

Outer sachet 100mg CD/100mg LD and inner sachet 0mg CD /300mg LD

DRUGlevodopa/carbidopa oral formulation B

Outer sachet 100mg CD/0mg LD and inner sachet 0mg CD /400mg LD

Locations(1)

University of Minnesota

Minneapolis, Minnesota, United States

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NCT05471609

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