Sustained Release Oral Formulation For Treatment Of Parkinsons Disease
University of Minnesota
Summary
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.
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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.
Interventions
- DrugFormulation A
outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD
- DrugFormulation B
outer sachet 150mg CD/0mg LD and inner sachet 600mg LD
- DrugFormulation C
outer sachet 200mg CD/0mg LD and inner sachet 800mg LD
Location
- University of MinnesotaMinneapolis, Minnesota