drugset / Trial / NCT03887884

Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)

NCT03887884

Phase 1 Completed 23 enrolled Acorda Therapeutics
RandomizedCrossoverOpen-labelOther

Summary

This study will be an open-label, randomized, multi-center, 2-way crossover Pharmacokinetic PK evaluation of a single inhaled dose of CVT-301 84 mg and a single oral dose of carbidopa/levodopa CD/LD 25 mg/100 mg (Sinemet®) under fed conditions in Parkinson's Disease (PD) patients who regularly take CD/LD.

Timeline

Start
2019-03-05
Primary completion
2019-06-28
Completion
2019-06-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Levodopa Small molecule 84 mg Inhaled
Subject Levodopa Small molecule 100 mg Oral
Background Carbidopa Unknown 25 mg Oral

Indications