Sustained Release Oral Formulation for Treatment of Parkinson's Disease

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Normal healthy
Are 18-65 years of age
Are not currently taking medications regularly
Able to fast 6 hours (water allowed)

Exclusion criteria

Pregnancy
Inability to fast

Treatment and study plan

levodopa/carbidopa oral formulation A

Drug

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

levodopa/carbidopa oral formulation B

Drug

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

Primary outcomes

Carbidopa/levodopa serum level Efficacy of the delivery method

Time frame: 4 times, then every 60 mins for a total of 6 hours after administration (total of 9 blood samples)

Carbidopa/levodopa serum level

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jul 25, 2022
Registry last updated: Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed