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Single-dose pharmacokinetics of paliperidone extended-release tablets in healthy Chinese subjects
Si Tianmei; Shu Liang; Liu Yi; Su Yun′ Ai; Guo Chunmei; Zhang Hongyan
关键词Chinese PalipEridone Er Pharmacokinetics Tolerability
刊名HUMAN PSYCHOPHARMACOLOGY-CLINICAL AND EXPERIMENTAL
2010-07-01
DOI10.1002/hup.1132
25期:5页:404-409
收录类别SCI
文章类型Article
WOS标题词Science & Technology ; Social Sciences
类目[WOS]Clinical Neurology ; Pharmacology & Pharmacy ; Psychiatry ; Psychology
资助者JJPRD ; ALZA Corporation ; JJPRD ; ALZA Corporation
研究领域[WOS]Neurosciences & Neurology ; Pharmacology & Pharmacy ; Psychiatry ; Psychology
关键词[WOS]LONG-TERM TREATMENT ; CHRONIC-SCHIZOPHRENIA ; DOUBLE-BLIND ; RISPERIDONE ; EFFICACY ; SAFETY ; 9-HYDROXYRISPERIDONE ; TOLERABILITY ; HALOPERIDOL ; MULTICENTER
英文摘要

Objective Paliperidone is the active metabolite of risperidone. This single-center, double-blind, randomized, single-dose study characterized the pharmacokinetics of 3mg and 9mg of paliperidone ER OROS (R) in healthy Chinese subjects.

Methods 24 subjects (13 male, 11 female), aged 19-35 years, with a BMI of 19.0-24.6 kg/m(2) participated. Blood samples were collected immediately before and over 96 h following single oral doses of 3mg and 9mg paliperidone. Plasma paliperidone concentrations were determined, and pharmacokinetic parameters were analyzed.

Results Paliperidone′s disposition after oral administration was characterized by a one-compartment pharmacokinetic model. Paliperidone was well absorbed (median t(max): 24 h after a 3-mg dose, and 26 h after a 9-mg dose). Apparent clearance and apparent volume of distribution were not significantly different between the two doses. C(max), AUC(0-t), and AUC(0-infinity) were dose-dependent. Pharmacokinetics was linear with respect to time; Geometric mean t(1/2) was 22.8 h and 21.4 h in 3-mg and 9-mg groups, respectively. No clinically significant safety issues were identified.

Conclusions The pharmacokinetic results obtained in Chinese subjects were similar to those obtained in Japanese and Caucasian subjects. Copyright (C) 2010 John Wiley & Sons, Ltd.

语种英语
资助者JJPRD ; ALZA Corporation ; JJPRD ; ALZA Corporation
WOS记录号WOS:000279355100006
Citation statistics
Cited Times:5[WOS]   [WOS Record]     [Related Records in WOS]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/53901
Collection北京大学精神卫生研究所
作者单位Peking Univ, Dept Clin Psychopharmacol, Inst Mental Hlth, Beijing 100191, Peoples R China
Recommended Citation
GB/T 7714
Si Tianmei,Shu Liang,Liu Yi,et al. Single-dose pharmacokinetics of paliperidone extended-release tablets in healthy Chinese subjects[J]. HUMAN PSYCHOPHARMACOLOGY-CLINICAL AND EXPERIMENTAL,2010,25(5):404-409.
APA Si Tianmei.,Shu Liang.,Liu Yi.,Su Yun&prime.,Ai.,...&Zhang Hongyan.(2010).Single-dose pharmacokinetics of paliperidone extended-release tablets in healthy Chinese subjects.HUMAN PSYCHOPHARMACOLOGY-CLINICAL AND EXPERIMENTAL,25(5),404-409.
MLA Si Tianmei,et al."Single-dose pharmacokinetics of paliperidone extended-release tablets in healthy Chinese subjects".HUMAN PSYCHOPHARMACOLOGY-CLINICAL AND EXPERIMENTAL 25.5(2010):404-409.
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