Sustained Release Oral Formulation for Treatment of Parkinson's Disease
NCT ID: NCT05471609
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
6 participants
INTERVENTIONAL
2025-06-12
2026-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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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.
levodopa/carbidopa oral formulation A
Outer sachet 100mg CD/100mg LD and inner sachet 0mg CD /300mg LD
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.
levodopa/carbidopa oral formulation B
Outer sachet 100mg CD/0mg LD and inner sachet 0mg CD /400mg LD
Interventions
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levodopa/carbidopa oral formulation A
Outer sachet 100mg CD/100mg LD and inner sachet 0mg CD /300mg LD
levodopa/carbidopa oral formulation B
Outer sachet 100mg CD/0mg LD and inner sachet 0mg CD /400mg LD
Eligibility Criteria
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Inclusion Criteria
* Are 18-65 years of age
* Are not currently taking medications regularly
* Able to fast 6 hours (water allowed)
Exclusion Criteria
* Inability to fast
18 Years
65 Years
ALL
Yes
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Khalaf Bushara, MD,FRCP
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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