Phase 1CompletedAge-related condition
A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
A Phase 1 Single Dose Pharmacokinetic Bridging Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
- Sponsor
- Acorda Therapeutics (Industry)
- Enrollment
- 24 enrolled
- Conditions
- Parkinson Disease
- Interventions
- CVT-301 (Dose Level 1); CVT-301 (Dose Level 2); Sinemet®
- Ages
- adults, older adults
- Registry
- NCT02812394
Full record on ClinicalTrials.gov
From the registry
This study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered carbidopa/levodopa, in healthy volunteers.
Primary outcomes
- Maximum observed plasma drug concentration (Cmax)
- Area under the plasma concentration curve from time 0 to the concentration at 24 hours (AUC0-24h)
History
Last registry update
Study completion
Primary completion
Registered
Started