Foslevodopa/foscarbidopa subcutaneous infusion maintains equivalent levodopa exposure to levodopa-carbidopa intestinal gel delivered to the jejunum.

Autor: Rosebraugh M; Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL, USA. Electronic address: matthew.rosebraugh@abbvie.com., Stodtmann S; Clinical Pharmacology and Pharmacometrics, AbbVie GmbH & Co KG, Germany., Liu W; Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL, USA., Facheris MF; Neuroscience Development, AbbVie, North Chicago, IL, USA.
Jazyk: angličtina
Zdroj: Parkinsonism & related disorders [Parkinsonism Relat Disord] 2022 Apr; Vol. 97, pp. 68-72. Date of Electronic Publication: 2022 Mar 22.
DOI: 10.1016/j.parkreldis.2022.03.012
Abstrakt: Introduction: The 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.
Methods: This was a Phase 1, open-label, randomized, 2-period crossover study conducted in 25 male and female healthy volunteers.
Results: The LD exposures (C max0-16 , AUC 0-16 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.
Conclusion: Foslevodopa/foscarbidopa subcutaneous infusion provides levodopa exposures comparable to LCIG throughout the day.
Gov Identifier: Not Applicable.
(Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: