Sustained‑release oral carbidopa/levodopa for Parkinson's
Sustained Release Oral Formulation for Treatment of Parkinson's Disease
This study will test whether two new sustained‑release oral formulations of carbidopa/levodopa produce steady blood levels in healthy adults.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05471609 on ClinicalTrials.gov |
What this trial studies
This is an early Phase 1, single‑center trial in healthy volunteers comparing two oral carbidopa/levodopa formulations. Participants will receive one of the formulations and have blood levels of levodopa and carbidopa measured over time to determine how steady the drug concentrations remain. Subjects must be healthy adults aged 18–65 who are not taking regular medications and can fast as required. The study is conducted at the University of Minnesota and focuses on pharmacokinetic performance rather than clinical effects in people with Parkinson's disease.
Who should consider this trial
Good fit: Healthy adults aged 18–65 who are not taking regular medications and can fast as required are ideal candidates for this study.
Not a fit: People who are pregnant, unable to fast, currently taking regular medications, or outside the 18–65 age range are not appropriate for this study and are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, a sustained‑release oral formulation could reduce motor fluctuations and simplify medication schedules for people with Parkinson's disease.
How similar studies have performed: Other extended‑release and sustained‑delivery levodopa approaches have shown partial success at smoothing plasma levodopa levels, but new formulations are still being developed to improve consistency and clinical benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Normal healthy * Are 18-65 years of age * Are not currently taking medications regularly * Able to fast 6 hours (water allowed) Exclusion Criteria: * Pregnancy * Inability to fast
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Khalaf Bushara, MD,FRCP — University of Minnesota
- Study coordinator: Research Coordinator
- Email: umnstudies@gmail.com
- Phone: 507-339-4093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.