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学科主题: 精神卫生
题名:
Pharmacokinetics and tolerability of paliperidone palmitate injection in Chinese subjects
作者: Si, Tianmei1,2; Su, Yun′ ai1,2; Liu, Yi1,2; Zhang, Hongyan1,2; Li, Huafang3; Rui, Qing4; Shu, Liang1,2
关键词: pharmacokinetics ; paliperidone palmitate ; Chinese
刊名: HUMAN PSYCHOPHARMACOLOGY-CLINICAL AND EXPERIMENTAL
发表日期: 2014-03-01
DOI: 10.1002/hup.2388
卷: 29, 期:2, 页:203-210
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
研究领域[WOS]: Neurosciences & Neurology ; Pharmacology & Pharmacy ; Psychiatry ; Psychology
关键词[WOS]: EXTENDED-RELEASE TABLETS ; SWITCHING STABLE PATIENTS ; ORAL ANTIPSYCHOTICS ; DOUBLE-BLIND ; SCHIZOPHRENIA ; SAFETY ; EFFICACY ; RISPERIDONE ; SCALE ; 6-WEEK
英文摘要:

ObjectiveThe objective of this study was to characterize the pharmacokinetics of 25, 100, and 150mg equivalents (eq.) of paliperidone long-acting injection in Chinese subjects with schizophrenia.

MethodsThis was an open-label, randomized, parallel group, multicenter study. A total of 48 patients were randomized in a 1:1:1 ratio to one of three groups. Sequential blood samples were collected immediately before injection on day1 and up to 210days after the first injection. The plasma paliperidone concentrations were determined by a validated high-performance liquid chromatography/tandem mass spectrometry method.

ResultsA total of 47 patients received at least one injection of the study medication, and 43 completed the study. The pharmacokinetic (PK) parameters, such as time to maximum concentration, t1/2, and CL/F, were comparable across the three treatment groups (p=0.935, 0.349, and 0.794, respectively). The differences in maximum plasma concentration, AUC (035days), AUC (0-210days), and AUC (0-) were significant (p<0.001) and dose proportional. The inter-individual variation of PK parameters was large. The most frequent treatment-emergent adverse events were prolactin level increasing, injection site pain, tremor, dry mouth, and constipation.

ConclusionsThe pharmacokinetics of paliperidone palmitate are linear with respect to time in Chinese subjects with schizophrenia at injections from 25 to 150mg eq. Copyright (c) 2014 John Wiley & Sons, Ltd.

语种: 英语
项目资助者: Johnson &amp ; Johnson Pharmaceutical Research Development
WOS记录号: WOS:000333015700012
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/63960
Appears in Collections:北京大学精神卫生研究所_期刊论文

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作者单位: 1.Peking Univ, Inst Mental Hlth, Dept Clin Psychopharmacol, Beijing 100191, Peoples R China
2.Peking Univ, Minist Hlth, Key Lab Mental Hlth, Beijing 100191, Peoples R China
3.Shanghai Mental Hlth Ctr, Shanghai, Peoples R China
4.Xian Janssen Pharmaceut Ltd, China R&D & Sci Affairs, Beijing, Peoples R China

Recommended Citation:
Si, Tianmei,Su, Yun&prime,ai,et al. Pharmacokinetics and tolerability of paliperidone palmitate injection in Chinese subjects[J]. HUMAN PSYCHOPHARMACOLOGY-CLINICAL AND EXPERIMENTAL,2014,29(2):203-210.
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