Article(id=1292130264092795544, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130221843571059, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.08.020, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1770220800000, receivedDateStr=2026-02-05, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997461578, onlineDateStr=2026-08-06, pubDate=1777305600000, pubDateStr=2026-04-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997461578, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997461578, creator=13701087609, updateTime=1785997461578, updator=13701087609, issue=Issue{id=1292130221843571059, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='8', pageStart='1051', pageEnd='1200', issueExtLink='null', onlineDate='null', pubDate='1777305600000', pubDateStr='2026-04-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997451505, creator='13701087609', updateTime=1786014411018, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201355276480844, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130221843571059, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201355276480845, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130221843571059, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1176, endPage=1181, ext={EN=ArticleExt(id=1292130264285733529, articleId=1292130264092795544, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Bioequivalence study of pregabalin capsules in Chinese healthy 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 test preparation and reference preparation of pregabalin capsule in Chinese healthy subjects under fasting and fed conditions.
Methods Using a single center, randomized, open, two cycle crossover design, 52 healthy subjects were divided into fasting group and fed group, with 26 cases in each group. The test or reference preparation of pregabalin capsules was orally administered 150 mg once. The blood concentration was determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and pharmacokinetic (PK) parameters were calculated to evaluate the bioequivalence.
Results The main PK parameters Cmax of pregabalin capsule test preparation and reference preparation in the fasting group were (6 722.00±1 390.00) and (6 065.00±1 218.00) ng·mL-1, respectively; AUC0-t were (32 570.52±3 877.48) and (32 721.93±4 270.54) ng·h·mL-1, respectively; AUC0-∞ were (32 941.98±4 040.07) and (33 097.11±4 428.89) ng·h·mL-1, respectively; tmax was 0.75 (0.50, 1.75) and 1.00 (0.50, 1.75) h, respectively; the t1/2 were (5.58±0.74) and (5.55±0.80) h, respectively. The main PK parameters Cmax of the test preparation and reference preparation of pregabalin capsules in the fed group were (3 786.00±513.90) and (3 786.00±437.50) ng·ml-1, respectively; AUC0-t were (32 760.51±4 250.79) and (31 923.83±3 842.92) ng·h·mL-1, respectively; AUC0-∞ were (33 371.21±4 406.02) and (32 519.87±4 050.39) ng·h·mL-1, respec tively; tmax was 3.50 (2.50, 4.50) and 3.00 (2.50, 4.51) h, respectively; the t1/2 was (5.95±0.79) and (5.89±0.91) h, respectively. Under fasting or fed conditions, the 90% confidence intervals of the main PK parameters of the test preparation and the reference preparation were both 80.00%-125.00%.
Conclusion The test preparation and reference preparation of pregabalin capsules are bioequivalent under fasting and fed conditions.
, authors=Yun-shan HE
1, Jian-jun ZHOU
1, Cao-fang HE
2, Niu-xiu LI
2, authorsList=Yun-shan HE, Jian-jun ZHOU, Cao-fang HE, Niu-xiu LI, authorCompany=null, correspAuthors=Cao-fang HE, Niu-xiu LI, 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=1292130264524808858, articleId=1292130264092795544, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=普瑞巴林胶囊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 研究空腹及餐后状态下口服普瑞巴林胶囊受试制剂与参比制剂在中国健康受试者体内的生物等效性。
方法 用单中心、随机、开放、两周期交叉设计，入组52例健康受试者，空腹和餐后给药组各26例，单次口服普瑞巴林胶囊受试制剂或参比制剂150 mg，以液相色谱-串联质谱联用技术（LC-MS/MS）测定血药浓度并计算药代动力学（PK）参数，评价生物等效性。
结果 空腹给药组的普瑞巴林胶囊受试制剂和参比制剂主要PK参数Cmax分别为（6 722.00±1 390.00）和（6 065.00±1 218.00）ng·mL-1；AUC0-t分别为（32 570.52±3 877.48）和（32 721.93±4 270.54）ng·h·mL-1；AUC0-∞分别为（32 941.98±4 040.07）和（33 097.11±4 428.89）ng·h·mL-1；tmax分别为0.75（0.50，1.75）和1.00（0.50，1.75）h；t1/2分别为（5.58±0.74）和（5.55±0.80）h。餐后给药组的普瑞巴林胶囊受试制剂和参比制剂主要PK参数Cmax分别为（3 786.00±513.90）和（3 786.00±437.50）ng·mL-1；AUC0-t分别为（32 760.51±4 250.79）和（31 923.83±3 842.92）ng·h·mL-1；AUC0-∞分别为（33 371.21±4 406.02）和（32 519.87±4 050.39）ng·h·mL-1；tmax分别为3.50（2.50，4.50）和3.00（2.50，4.51）h；t1/2分别为（5.95±0.79）和（5.89±0.91）h。在空腹或餐后条件下，受试制剂与参比制剂主要PK参数的90%置信区间均在80.00%~125.00%。
结论 普瑞巴林胶囊受试制剂和参比制剂在空腹和餐后状态下生物等效。
, authors=何云山
1, 周建军
1, 何草芳
2, 李牛秀
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何云山（1995-），男，主管药师，主要从事药物临床试验相关工作和研究
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