Sustained Release Oral Formulation For Treatment Of Parkinsons Disease

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07709741
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Formulation A — DRUG
    outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD
  • Formulation B — DRUG
    outer sachet 150mg CD/0mg LD and inner sachet 600mg LD
  • Formulation C — DRUG
    outer sachet 200mg CD/0mg LD and inner sachet 800mg LD

Study Details

LD/CD (medications to treat Parkinson's disease) will be delivered using an assembly of nested sachets made of permeable material. The assembly is 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. The combination of CD/LD in the inner sachet varies from that in the outer sachet. This allows for sequential release of CD and then LD to mimic a CD pretreatment method which is known to increase LD absorption and prolong its half-life.

Key Dates

First listed
Jul 16, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Active Comparator: Formulation A
    Two sachets nested between the lower jaw, gum, and cheek; outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD
  • Active Comparator: Formulation B
    Two sachets nested between the lower jaw, gum, and cheek; outer sachet 150mg CD/0mg LD and inner sachet 600mg LD
  • Active Comparator: Formulation C
    Two sachets nested between the lower jaw, gum, and cheek; outer sachet 200mg CD/0mg LD and inner sachet 800mg LD

Primary Outcome Measure

Blood CD Level - Minute 15 [ Time Frame: Minute 15 after administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Khalaf Bushara, MD, FRCP
[email protected]
612-725-2000
Khalaf Bushara, MD, FRCP (PRINCIPAL_INVESTIGATOR)

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By research site
University of Minnesota· Minneapolis, MN

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