Sustained Release Oral Formulation for Treatment of Parkinson's Disease

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT05471609
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jun 12, 2025
Status verified
Jul 2025
Primary completion
Jun 16, 2026
Completion
Jun 16, 2026

Study Design

Enrollment
6 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Research Coordinator
[email protected]
507-339-4093

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By research site
University of Minnesota· Minneapolis, MN

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