MedTrace Logo

Sustained Release Oral Formulation For Treatment Of Parkinsons Disease

NCT07709741 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-08-10

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Formulation A

outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD

DRUG

Formulation B

outer sachet 150mg CD/0mg LD and inner sachet 600mg LD

DRUG

Formulation C

outer sachet 200mg CD/0mg LD and inner sachet 800mg LD

Sponsors & Collaborators

Principal Investigators

  • Khalaf Bushara, MD, FRCP · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07709741 on ClinicalTrials.gov