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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Formulation A; Drug: Formulation B; Drug: Formulation C

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Khalaf Bushara, MD, FRCP; Phone Number: ‪(612) 460-5734‬; Email: umnstudies@gmail.com

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
      • Contact: Khalaf Bushara, MD, FRCP; Phone Number: x4233 612-725-2000; Email: busha001@umn.edu
      • Principal Investigator: Khalaf Bushara, MD, FRCP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Formulation A; 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; outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD; Other Names: Study Drug A
Active Comparator: Formulation B; Two sachets nested between the lower jaw, gum, and cheek; outer sachet 150mg CD/0mg LD and inner sachet 600mg LD	Drug: Formulation B; outer sachet 150mg CD/0mg LD and inner sachet 600mg LD; Other Names: Study Drug B
Active Comparator: Formulation C; 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 200mg CD/0mg LD and inner sachet 800mg LD; Other Names: Study Drug C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Khalaf Bushara, MD, FRCP, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Carbidopa; Parkinson's; Levidopa
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: NEUR-2021-29687

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No