Sustained Release Oral Formulation For Treatment Of Parkinsons Disease

Sustained Release Oral Formulation For Treatment Of Parkinsons Disease

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.

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.

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.