Trials / Recruiting
RecruitingNCT05471609
Sustained Release Oral Formulation for Treatment of Parkinson's Disease
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- Sponsor
- University of Minnesota · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
Achieving sustained blood levels of carbidopa/levodopa has been a challenge in the treatment of PD and although levodopa remains the most commonly used drug, motor fluctuations remain a major disability especially in advanced Parkinson's disease. The aim of this study is to determine the efficacy of a novel oral carbidopa-levodopa formulation in achieving a sustained blood level of levodopa and carbidopa in normal volunteers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | levodopa/carbidopa oral formulation A | Outer sachet 100mg CD/100mg LD and inner sachet 0mg CD /300mg LD |
| DRUG | levodopa/carbidopa oral formulation B | Outer sachet 100mg CD/0mg LD and inner sachet 0mg CD /400mg LD |
Timeline
- Start date
- 2025-06-12
- Primary completion
- 2026-06-16
- Completion
- 2026-06-16
- First posted
- 2022-07-25
- Last updated
- 2025-07-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05471609. Inclusion in this directory is not an endorsement.