Pharmacokinetics, safety, and tolerability of rotigotine transdermal system in healthy Japanese and Caucasian subjects following multiple-dose administration
作者: Willi CawelloSeong Ryul KimMarina BraunJan-Peer ElshoffTakeuchi MasahiroJunji IkedaTomoo Funaki
作者单位: 1UCB Pharma
2Otsuka Pharmaceutical Co., Ltd.
3Kitassato University
刊名: European Journal of Drug Metabolism and Pharmacokinetics, 2016, Vol.41 (4), pp.353-362
来源数据库: Springer Journal
DOI: 10.1007/s13318-015-0273-6
关键词: Dopamine agonistEthnic groupsJapanese/Caucasian comparisonMultiple dosesPharmacokineticsRotigotineTransdermal delivery
英文摘要: Abstract(#br)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...
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关键词翻译
关键词翻译
  • safety 安全
  • following 追踪
  • system 
  • Japanese 日本人日语日本的
  • multiple 多次的
  • healthy 健康的
  • administration 管理
  • transdermal 穿过表皮的
  • tolerability 可容许性