Pharmacokinetics, Tolerability, and Bioequivalence of Two Formulations of Rotigotine in Healthy Chinese Subjects
作者: Yun LiuBrian TomlinsonJiyuan GuoMahnaz AsgharnejadLars BauerErwin SurmannXiaojuan GuoJan-Peer Elshoff
作者单位: 1Shanghai Xuhui Central Hospital, Shanghai City, China
2Prince of Wales Hospital, Sha Tin, Hong Kong
3UCB Pharma, Shanghai City, China
4UCB Pharma, Raleigh, North Carolina
5UCB Pharma, Monheim am Rhein, Germany
刊名: Clinical Therapeutics, 2018, Vol.40 (7), pp.1108-1121.e8
来源数据库: Elsevier Journal
DOI: 10.1016/j.clinthera.2018.05.009
关键词: BioequivalenceChineseDopamine agonistPharmacokineticsRotigotineTolerabilityTransdermal delivery
原始语种摘要: ABSTRACT(#br)Purpose(#br)The pharmacokinetic (PK) profile of the rotigotine transdermal patch is well characterized in Caucasian patients with Parkinson's disease (PD) but not in Chinese subjects. This article reports the PK variables, safety, and tolerability of the rotigotine transdermal patch (2 mg/24 hours and 4 mg/24 hours cold-chain PR2.1.1 formulation) in healthy Chinese subjects (SP0913; NCT01675024). A second study (PD0011; NCT02070796) evaluated the relative bioavailability of cold-chain (PR2.1.1) and room temperature–stable (PR2.2.1) formulations of rotigotine in healthy Chinese men.(#br)Methods(#br)In treatment period 1 of SP0913, subjects received a single application of rotigotine 2 mg/24 hours on day 1 followed by a washout period (days 2–6); treatment period 2 (days 6–14)...
全文获取路径: Elsevier  (合作)
影响因子:2.23 (2012)

  • unconjugated 非结合的
  • transdermal 穿过表皮的
  • concentrations 浓聚物
  • formulation 配方
  • washout 冲蚀
  • patch 斑点
  • tolerability 可容许性
  • healthy 健康的
  • total 总和
  • single 单独的