A Phase 1/2 interventional study of Formulation A and Formulation B in Healthy Volunteers, sponsored by University of Minnesota. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by University of Minnesota · Phase 1/2, Interventional, and Other
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's planned enrollment of 32 is below the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Two sachets nested between the lower jaw, gum, and cheek; outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD
Drug: Formulation A
Two sachets nested between the lower jaw, gum, and cheek; outer sachet 150mg CD/0mg LD and inner sachet 600mg LD
Drug: Formulation B
Two sachets nested between the lower jaw, gum, and cheek; outer sachet 200mg CD/0mg LD and inner sachet 800mg LD
Drug: Formulation C
outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD
Also known as: Study Drug A
outer sachet 150mg CD/0mg LD and inner sachet 600mg LD
Also known as: Study Drug B
outer sachet 200mg CD/0mg LD and inner sachet 800mg LD
Also known as: Study Drug C
Blood CD Level - Minute 15
Measured in \[ng/mL\]
Time frame: Minute 15 after administration
Blood LD Level - Minute 15
Measured in \[ng/mL\]
Time frame: Minute 15 after administration
Blood CD Level - Minute 30
Measured in \[ng/mL\]
Time frame: Minute 30 after administration
Blood LD Level - Minute 30
Measured in \[ng/mL\]
Time frame: Minute 30 after administration
Blood CD Level - Minute 45
Measured in \[ng/mL\]
Time frame: Minute 45 after administration
Blood LD Level - Minute 45
Measured in \[ng/mL\]
Time frame: Minute 45 after administration
Blood CD Level - Hour 1
Measured in \[ng/mL\]
Time frame: One hour after administration
Blood LD Level - Hour 1
Measured in \[ng/mL\]
Time frame: One hour after administration
Blood CD Level - Hour 2
Measured in \[ng/mL\]
Time frame: Two hours after administration
Blood LD Level - Hour 2
Measured in \[ng/mL\]
Time frame: Two hours after administration
Blood CD Level - Hour 3
Measured in \[ng/mL\]
Time frame: Three hours after administration
Blood LD Level - Hour 3
Measured in \[ng/mL\]
Time frame: Three hours after administration
Blood CD Level - Hour 4
Measured in \[ng/mL\]
Time frame: Four hours after administration
Blood LD Level - Hour 4
Measured in \[ng/mL\]
Time frame: Four hours after administration
Blood CD Level - Hour 5
Measured in \[ng/mL\]
Time frame: Five hours after administration
Blood LD Level - Hour 5
Measured in \[ng/mL\]
Time frame: Five hours after administration
Blood CD Level - Hour 6
Measured in \[ng/mL\]
Time frame: Six hours after administration
Blood LD Level - Hour 6
Measured in \[ng/mL\]
Time frame: Six hours after administration
Blood CD Level - Hour 7
Measured in \[ng/mL\]
Time frame: Seven hours after administration
Blood LD Level - Hour 7
Measured in \[ng/mL\]
Time frame: Seven hours after administration
Blood CD Level - Hour 8
Measured in \[ng/mL\]
Time frame: Eight hours after administration
Blood LD Level - Hour 8
Measured in \[ng/mL\]
Time frame: Eight hours after administration
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of Minnesota