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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation A | Active Comparator | Two sachets nested between the lower jaw, gum, and cheek; outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD |
|
| Formulation B | Active Comparator | Two sachets nested between the lower jaw, gum, and cheek; outer sachet 150mg CD/0mg LD and inner sachet 600mg LD |
|
| Formulation C | Active Comparator | Two sachets nested between the lower jaw, gum, and cheek; outer sachet 200mg CD/0mg LD and inner sachet 800mg LD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formulation A | Drug | outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood CD Level - Minute 15 | Measured in [ng/mL] | Minute 15 after administration |
| Blood LD Level - Minute 15 | Measured in [ng/mL] | Minute 15 after administration |
| Blood CD Level - Minute 30 | Measured in [ng/mL] | Minute 30 after administration |
| Blood LD Level - Minute 30 | Measured in [ng/mL] | Minute 30 after administration |
| Blood CD Level - Minute 45 | Measured in [ng/mL] | Minute 45 after administration |
| Blood LD Level - Minute 45 | Measured in [ng/mL] | Minute 45 after administration |
| Blood CD Level - Hour 1 | Measured in [ng/mL] | One hour after administration |
| Blood LD Level - Hour 1 | Measured in [ng/mL] | One hour after administration |
| Blood CD Level - Hour 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khalaf Bushara, MD, FRCP | Contact | ‪(612) 460-5734‬ | umnstudies@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Khalaf Bushara, MD, FRCP | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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| 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 |
|
|
Measured in [ng/mL]
| Two hours after administration |
| Blood LD Level - Hour 2 | Measured in [ng/mL] | Two hours after administration |
| Blood CD Level - Hour 3 | Measured in [ng/mL] | Three hours after administration |
| Blood LD Level - Hour 3 | Measured in [ng/mL] | Three hours after administration |
| Blood CD Level - Hour 4 | Measured in [ng/mL] | Four hours after administration |
| Blood LD Level - Hour 4 | Measured in [ng/mL] | Four hours after administration |
| Blood CD Level - Hour 5 | Measured in [ng/mL] | Five hours after administration |
| Blood LD Level - Hour 5 | Measured in [ng/mL] | Five hours after administration |
| Blood CD Level - Hour 6 | Measured in [ng/mL] | Six hours after administration |
| Blood LD Level - Hour 6 | Measured in [ng/mL] | Six hours after administration |
| Blood CD Level - Hour 7 | Measured in [ng/mL] | Seven hours after administration |
| Blood LD Level - Hour 7 | Measured in [ng/mL] | Seven hours after administration |
| Blood CD Level - Hour 8 | Measured in [ng/mL] | Eight hours after administration |
| Blood LD Level - Hour 8 | Measured in [ng/mL] | Eight hours after administration |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |