Abstract
IntroductionThe objective of this study was to compare the pharmacokinetics (PK) of levodopa (LD) from 24-h continuous subcutaneous infusion of foslevodopa/foscarbidopa to the LD pharmacokinetics from 16-h levodopa-carbidopa intestinal gel (LCIG) followed by night-time oral LD/carbidopa (CD) doses. MethodsThis was a Phase 1, open-label, randomized, 2-period crossover study conducted in 25 male and female healthy volunteers. ResultsThe LD exposures (Cmax0-16, AUC0-16 and AUC∞) following subcutaneous infusion of 700/35 mg foslevodopa/foscarbidopa over 24 h were similar (<8% difference) to those of LCIG 350/87.5 mg LD/CD administered over 16 h followed by two 100/25 mg LD/CD oral doses at 18 and 21 h after the start of LCIG delivery. ConclusionFoslevodopa/foscarbidopa subcutaneous infusion provides levodopa exposures comparable to LCIG throughout the day. ClinicalTrials.gov identifierNot Applicable.
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