drugset / Trial / NCT07709741
Sustained Release Oral Formulation For Treatment Of Parkinsons Disease
RandomizedCrossoverDouble-blindOther
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.
Timeline
- Start
- 2026-06-30
- Primary completion
- 2027-06-30
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carbidopa | Unknown | 100 mg | Oral |
| Comparator | Carbidopa | Unknown | 150 mg | Oral |
| Comparator | Carbidopa | Unknown | 200 mg | Oral |
| Comparator | Levidopa | Unknown | 400 mg | Oral |
| Comparator | Levidopa | Unknown | 600 mg | Oral |
| Comparator | Levidopa | Unknown | 800 mg | Oral |
Indications
No indication recorded.