title: Levodopa-Carbidopa Intestinal Gel Pharmacokinetics: Lower Variability than Oral Levodopa-Carbidopa.
abstract: In a double-blind, double-dummy, double-titration Phase 3 trial in advanced Parkinson's disease (PD) patients, the efficacy and safety of Levodopa-carbidopa intestinal gel (LCIG) infusion were characterized relative to immediate-release oral levodopa-carbidopa (LC-oral) treatment. We present in this report the comparative pharmacokinetic profiles of LCIG and LC-oral from this pivotal study. The results presented in this report clearly demonstrate that LCIG results in lower variability and fluctuations in levodopa and carbidopa plasma concentrations compared to LC-oral. The superior pharmacokinetic profiles with LCIG were consistent with its improved efficacy compared to LC-oral as demonstrated in this study.
authors.affiliation: Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL, USA.
authors.forename: Ahmed A
authors.initials: AA
authors.lastname: Othman
authors.affiliation: Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL, USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Rosebraugh
authors.affiliation: Former Employee of Neuroscience Development, AbbVie, North Chicago, IL, USA.
authors.forename: Krai
authors.initials: K
authors.lastname: Chatamra
authors.affiliation: Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Locke
authors.affiliation: Former Employee of Clinical Pharmacology and Pharmacometrics, AbbVie, North Chicago, IL, USA.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Dutta
mesh_terms: D000284:Administration, Oral; D000978:Antiparkinson Agents / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D002230:Carbidopa / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D004311:Double-Blind Method; D004338:Drug Combinations; D016503:Drug Delivery Systems; D005782:Gels / Q000627:therapeutic use; D006801:Humans; D007980:Levodopa / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D010300:Parkinson Disease / Q000188:drug therapy*
chemical_list: D000978:Antiparkinson Agents; D004338:Drug Combinations; D005782:Gels; C009265:carbidopa, levodopa drug combination; D007980:Levodopa; D002230:Carbidopa
keywords: Parkinson’s disease; levodopa/carbidopa intestinal gel; movement disorders; pharmacokinetics