Healthy Volunteers
Conditions
Keywords
Parkinson's, Levidopa, Carbidopa
Brief 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.
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
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
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Intervention model 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
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood CD Level - Minute 15 | Minute 15 after administration | Measured in \[ng/mL\] |
| Blood LD Level - Minute 15 | Minute 15 after administration | Measured in \[ng/mL\] |
| Blood CD Level - Minute 30 | Minute 30 after administration | Measured in \[ng/mL\] |
| Blood LD Level - Minute 30 | Minute 30 after administration | Measured in \[ng/mL\] |
| Blood CD Level - Minute 45 | Minute 45 after administration | Measured in \[ng/mL\] |
| Blood LD Level - Minute 45 | Minute 45 after administration | Measured in \[ng/mL\] |
| Blood CD Level - Hour 1 | One hour after administration | Measured in \[ng/mL\] |
| Blood LD Level - Hour 1 | One hour after administration | Measured in \[ng/mL\] |
| Blood CD Level - Hour 2 | Two hours after administration | Measured in \[ng/mL\] |
| Blood LD Level - Hour 2 | Two hours after administration | Measured in \[ng/mL\] |
| Blood CD Level - Hour 3 | Three hours after administration | Measured in \[ng/mL\] |
| Blood LD Level - Hour 3 | Three hours after administration | Measured in \[ng/mL\] |
| Blood CD Level - Hour 4 | Four hours after administration | Measured in \[ng/mL\] |
| Blood LD Level - Hour 4 | Four hours after administration | Measured in \[ng/mL\] |
| Blood CD Level - Hour 5 | Five hours after administration | Measured in \[ng/mL\] |
| Blood LD Level - Hour 5 | Five hours after administration | Measured in \[ng/mL\] |
| Blood CD Level - Hour 6 | Six hours after administration | Measured in \[ng/mL\] |
| Blood LD Level - Hour 6 | Six hours after administration | Measured in \[ng/mL\] |
| Blood CD Level - Hour 7 | Seven hours after administration | Measured in \[ng/mL\] |
| Blood LD Level - Hour 7 | Seven hours after administration | Measured in \[ng/mL\] |
| Blood CD Level - Hour 8 | Eight hours after administration | Measured in \[ng/mL\] |
| Blood LD Level - Hour 8 | Eight hours after administration | Measured in \[ng/mL\] |
Countries
United States
Contacts
CONTACTKhalaf Bushara, MD, FRCP
PRINCIPAL_INVESTIGATORKhalaf Bushara, MD, FRCP
University of Minnesota
Outcome results
None listed