Article(id=1291404871257813501, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404807152067353, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.08.018, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1735315200000, receivedDateStr=2024-12-28, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824514449, onlineDateStr=2026-08-04, pubDate=1745769600000, pubDateStr=2025-04-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824514449, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824514449, creator=13701087609, updateTime=1785824514449, updator=13701087609, issue=Issue{id=1291404807152067353, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='8', pageStart='1051', pageEnd='1200', issueExtLink='null', onlineDate='null', pubDate='1745769600000', pubDateStr='2025-04-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824499166, creator='13701087609', updateTime=1785824499166, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1152, endPage=1156, ext={EN=ArticleExt(id=1291404872797123070, articleId=1291404871257813501, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Bioequivalence study of haloperidol in healthy Chinese subjects, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective To study the bioequivalence of two formulations of haloperidol tablets in healthy Chinese subjects.
Methods The randomized, open, single dose, two periods, crossover study design was adopted in the study. Twenty-eight healthy subjects were enrolled under fasting condition and given either test preparation or reference preparation 2 mg respectively in one period. After collecting plasma samples, the plasma concentrations of haloperidol were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The pharmacokinetic parameters were calculated by WinNonlin 8.0 and the bioequivalence was evaluated using the average bioequivalence (ABE) method.
Results The pharmacokinetic parameters of haloperidol of the test preparation or reference preparation were as follow: Cmax were (719.50±378.43) and (703.43±329.63) pg·mL-1, AUC0-t were (1.94×104±6 766.21) and (1.94×104±6 522.79) pg·h·mL-1, AUC0-∞ were (2.31×104±7 693.66) and (2.30×104±7 309.97) pg·h·mL-1. The 90% confidence intervals (CI) of the geometric mean ratio (GMR) were 92.46%-114.76%, 96.70%-108.15%, 96.36%-111.34% for Cmax, AUC0-t and AUC0-∞, respectively, which were within the acceptance criteria of 80.00%-125.00%.
Conclusion The two preparations of haloperidol tablets were bioequivalent in Chinese healthy subjects.
, authors=Chun-chun FANG
1, Feng-jie LIANG
1, Hui-hui SONG
1, You-hong SHEN
1, Yu-sheng HE
2, Xiao-fen LOU
1, authorsList=Chun-chun FANG, Feng-jie LIANG, Hui-hui SONG, You-hong SHEN, Yu-sheng HE, Xiao-fen LOU, authorCompany=null, correspAuthors=Xiao-fen LOU, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291404873111695873, articleId=1291404871257813501, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=氟哌啶醇片在中国健康受试者中的生物等效性研究, columnId=1246531407988805834, journalTitle=中国临床药理学杂志, columnName=药代动力学与生物等效性研究, runingTitle=null, highlight=null, articleAbstract=
目的 评价氟哌啶醇片受试制剂与参比制剂在中国健康受试者中的生物等效性。
方法 用随机、开放、单剂量、两周期、双交叉设计，空腹试验入组28例健康受试者，每周期分别单次口服氟哌啶醇片受试制剂和参比制剂2 mg，采集血浆样本后用液相色谱串联质谱（LC-MS/MS）法测定血浆中氟哌啶醇的浓度，用WinNonlin 8.0软件计算药代动力学参数并用平均生物等效性（ABE）方法进行生物等效性评价。
结果 受试者服用氟哌啶醇片受试制剂与参比制剂后，氟哌啶醇的主要药代动力学参数：Cmax分别为（719.50±378.43）和（703.43±329.63）pg·mL-1，AUC0-t分别为（1.94×104±6 766.21）和（1.94×104±6 522.79）pg·h·mL-1，AUC0-∞分别为（2.31×104±7 693.66）和（2.30×104±7 309.97）pg·h·mL-1。Cmax、AUC0-t和AUC0-∞的几何均值比（GMR）的90%置信区间分别为92.46%~114.76%、96.70%~108.15%和96.36%~111.34%，均落在80.00%~125.00%。
结论 氟哌啶醇片受试制剂与参比制剂在中国健康受试者中具有生物等效性。
, authors=房纯纯
1, 梁峰杰
1, 宋慧慧
1, 沈幼红
1, 何愉胜
2, 娄晓芬
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房纯纯（1992-），女，中级工程师，主要从事药物临床试验方面的相关研究
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