Pharmacokinetics, safety, and tolerability of rotigotine transdermal system in healthy Japanese and Caucasian subjects following multiple-dose administration

European Journal of Drug Metabolism and Pharmacokinetics
Willi CawelloTomoo Funaki

Abstract

Rotigotine is a dopamine receptor agonist indicated for the treatment of Parkinson's disease and moderate-to-severe restless legs syndrome. Continuous transdermal delivery of rotigotine via a silicon-based patch maintains stable plasma concentrations over 24 h. The objective of the study was to evaluate the pharmacokinetics, safety, and tolerability of a multiple-dose schedule of rotigotine transdermal patch in Japanese and Caucasian subjects. In this open-label, repeated-dose, parallel-group study (ClinicalTrials.gov: NCT01854216), healthy male and female subjects of Japanese or Caucasian ethnic origin were matched by gender, body mass index, and age. Subjects underwent a 9-day patch application period. 12 Japanese and 12 Caucasian subjects were included in the pharmacokinetic analyses. Mean apparent doses (actual amount of drug delivered) increased proportionally with rotigotine nominal dosages (1, 2, and 4 mg/24 h) and were similar for both ethnic groups, with large inter-individual variability. Mean plasma concentration-time profiles for unconjugated rotigotine were similar in both ethnic groups at day 3 for each dosage. Peak concentrations (C max,ss) and area under the concentration-time curves from pre-dose to the concent...Continue Reading

References

Jun 5, 2003·American Journal of Epidemiology·Stephen K Van Den EedenLorene M Nelson
Dec 17, 2003·Archives of Neurology·UNKNOWN Parkinson Study Group
Apr 12, 2005·Movement Disorders : Official Journal of the Movement Disorder Society·Joseph Jankovic
Apr 18, 2007·Neurology·Peter A LeWittUNKNOWN SP 650 Study Group
Oct 16, 2007·Movement Disorders : Official Journal of the Movement Disorder Society·Nir GiladiUNKNOWN SP513 investigators
Aug 16, 2008·Naunyn-Schmiedeberg's Archives of Pharmacology·Dieter SchellerHermann Lübbert
Dec 2, 2008·Neuropsychiatric Disease and Treatment·Joseph Jankovic, L Giselle Aguilar
Dec 20, 2008·British Journal of Clinical Pharmacology·Marina BraunRolf Horstmann
Jul 18, 2009·Drug Metabolism and Disposition : the Biological Fate of Chemicals·Willi CawelloHilmar Boekens
Oct 6, 2009·Journal of Epidemiology·Weerasak MuangpaisanCarol Brayne
Jul 16, 2010·Movement Disorders : Official Journal of the Movement Disorder Society·Wayne A HeningUNKNOWN SP792 Study Group
Jan 26, 2011·Movement Disorders : Official Journal of the Movement Disorder Society·Pablo Martinez-MartinUNKNOWN NMSS Validation Group
Jun 29, 2011·British Journal of Clinical Pharmacology·Willi CawelloMarina Braun
Sep 4, 2012·European Journal of Neurology : the Official Journal of the European Federation of Neurological Societies·Diego Garcia-BorregueroUNKNOWN European Sleep Research Society

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Citations

Jan 15, 2018·European Journal of Drug Metabolism and Pharmacokinetics·Willi CawelloJens-Otto Andreas
Jun 28, 2019·CNS Drugs·James E Frampton
Jan 12, 2021·Movement Disorders Clinical Practice·Paloma Parra-DíazJuan Carlos Martínez-Castrillo

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