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Not yet recruiting NCT07709741

Sustained Release Oral Formulation For Treatment Of Parkinsons Disease

Phase I / Phase II Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Formulation A, Formulation B, Formulation C.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

This is a randomized, double-blind (dose-masked), single-dose crossover study to investigate the pharmacokinetics of a novel delivery method and formulation of different doses of CD/LD in normal volunteers.

Interventions

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

Primary outcome measures

  • Blood CD Level - Minute 15 [Time frame: Minute 15 after administration]
  • Blood LD Level - Minute 15 [Time frame: Minute 15 after administration]
  • Blood CD Level - Minute 30 [Time frame: Minute 30 after administration]
  • Blood LD Level - Minute 30 [Time frame: Minute 30 after administration]
  • Blood CD Level - Minute 45 [Time frame: Minute 45 after administration]
  • Blood LD Level - Minute 45 [Time frame: Minute 45 after administration]
  • Blood CD Level - Hour 1 [Time frame: One hour after administration]
  • Blood LD Level - Hour 1 [Time frame: One hour after administration]
  • Blood CD Level - Hour 2 [Time frame: Two hours after administration]
  • Blood LD Level - Hour 2 [Time frame: Two hours after administration]

Eligibility criteria

Inclusion criteria

  • Adult healthy male or female
  • Age 18 to 65 years
  • Willingness and ability to complete study procedures

Exclusion criteria

  • medical conditions that require taking medications regularly.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT07709741 · NEUR-2021-29687

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗