Article(id=1292130364735120284, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130254689165893, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.05.017, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1752508800000, receivedDateStr=2025-07-15, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997485573, onlineDateStr=2026-08-06, pubDate=1773676800000, pubDateStr=2026-03-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997485573, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997485573, creator=13701087609, updateTime=1785997485573, updator=13701087609, issue=Issue{id=1292130254689165893, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='5', pageStart='601', pageEnd='750', issueExtLink='null', onlineDate='null', pubDate='1773676800000', pubDateStr='2026-03-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997459337, creator='13701087609', updateTime=1786014469153, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201599108141219, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130254689165893, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201599108141220, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130254689165893, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=706, endPage=714, ext={EN=ArticleExt(id=1292130364953224093, articleId=1292130364735120284, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Bioequivalence of ezetimibe and atorvastatin calcium tablets in Chinese healthy subjects, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective To evaluate the bioequivalence and safety profile of ezetimibe and atorvastatin calcium tablets (10 mg/10 mg) in healthy subjects.
Methods This study utilized a single-center, randomized, open-label, four-period replicate crossover design. A total of 36 participants were enrolled for both fasting and fed state evaluations. Subjects, following a randomization plan, were administered orally either a single tablet of the test (T) or reference (R) formulation on the designated dosing day of each period. An 8-day washout interval separated treatment periods. Quantification of plasma levels for free ezetimibe, total ezetimibe (sum of free ezetimibe and its glucuronide conjugates) and atorvastatin were performed employing validated high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The pharmacokinetic parameters were analyzed using Phoenix WinNonlin 8.2 software, and the bioequivalence evaluation was conducted.
Results Fasting state was as following: pharmacokinetic metrics Cmax of ezetimibe for T and R formulations were (6.35±3.22) and (7.04±3.20) ng·mL-1; AUC0-t were (107.10±46.61) and (109.67±50.23) ng·h·mL-1; AUC0-∞ were (114.88±49.96) and (117.14±50.74) ng·h·mL-1. The 90% confidence intervals for the geometric mean ratio of Cmax, AUC0-t and AUC0-∞ were 84.11%-98.34%, 94.60%-106.44% and 93.52%-105.82%, respectively, all in the range of 80.00%-125.00%. Pharmacokinetic metrics Cmax of total ezetimibe for T and R formulations were (67.01±35.70) and (71.82±30.91) ng·mL-1; AUC0-t were (605.29±255.51) and (615.90±270.21) ng·h·mL-1; AUC0-∞ were (655.81±268.02) and (676.04±279.18) ng·h·mL-1. The 90% confidence intervals for the geometric mean ratio of Cmax, AUC0-t and AUC0-∞ were 85.32%-97.52%, 92.35%-103.46% and 91.43%-102.13%, all in the range of 80.00%-125.00%. Pharmacokinetic metrics Cmax of atorvastatin for T and R formulations were (4.28±2.50) and (4.06±2.40) ng·mL-1; AUC0-t were (24.24±18.91) and (22.12±10.80) ng·h·mL-1; AUC0-∞were (23.86±12.05) and (23.44±10.98) ng·h·mL-1. The individual coefficient of variation for Cmax with the one-sided 95% upper confidence limit below the zero boundary value. The geometric mean ratio for Cmax was 1.06, falling within the acceptance range 0.80-1.25. The 90% confidence intervals for the geometric mean ratios of AUC0-t and AUC0-∞ were 97.11%-109.14% and 97.24%-104.00%, all in the range of 80.00%-125.00%. The pharmacokinetic parameters of active ingredients in the fed group were as follows: for ezetimibe, the Cmax values of the test and reference preparations were (12.50±8.43) and (12.10±10.20) ng·mL-1, respectively; the AUC0-t values were (115.66±61.86) and (114.91±61.10) ng·h·mL-1, respectively; and the AUC0-∞ values were (127.40±66.49) and (128.37±66.73) ng·h·mL-1, respectively. The one-sided 95% upper confidence limit for ezetimibe Cmax was <0, with a GMR of 1.09, within the range of 0.80-1.25. The 90% confidence intervals for the geometric mean ratios of AUC0-t and AUC0-∞ were 93.63%-107.27% and 91.07%-108.13%, respectively, both within 80.00%-125.00%. For total ezetimibe, the Cmax values of the test and reference preparations were (102.02±50.21) and (95.10±48.31) ng·mL-1, respectively; the AUC0-t values were (660.62±342.67) and (645.43±290.84) ng·h·mL-1, respectively; the AUC0-∞ values were (728.80±356.15) and (711.88±301.04) ng·h·mL-1, respectively. The one-sided 95% upper confidence limit for total ezetimibe Cmax was <0, with a GMR of 1.08, within the range of 0.80-1.25. The 90% confidence intervals for the geometric mean ratios of AUC0-t and AUC0-∞ were 95.12%-106.95% and 95.27%-107.60%, respectively, both within 80.00%-125.00%. For atorvastatin, the Cmax values of the test and reference preparations were (1.79±0.80) and (1.83±0.87) ng·mL-1, respectively; the AUC0-t values were (19.09±6.85) and (18.24±6.29) ng·h·mL-1, respectively; and the AUC0-∞ values were (21.25±6.97) and (20.34±6.84) ng·h·mL-1, respectively. The 90% confidence intervals for the geometric mean ratios of Cmax, AUC0-t and AUC0-∞ were 91.25%-106.96%, 99.81%-108.09% and 100.22%-108.73%, respectively, all falling within the range of 80.00%-125.00%.
Conclusion The test formulation of ezetimibe and atorvastatin calcium tablets met bioequivalence criteria relative to the reference product in healthy subjects under both fasting and fed (high-fat meal) conditions.
, authors=Jin-jü SUN
1, Shuang LU
1, Hong-yun LI
1, Xiu-min LI
1, Jian-shu SU
2, Gang CHEN
3, Rui-chen GUO
4, Hua SU
1, authorsList=Jin-jü SUN, Shuang LU, Hong-yun LI, Xiu-min LI, Jian-shu SU, Gang CHEN, Rui-chen GUO, Hua SU, authorCompany=null, correspAuthors=Hua SU, 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=1292130365230048158, articleId=1292130364735120284, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=依折麦布阿托伐他汀钙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 评价依折麦布阿托伐他汀钙片在健康受试者体内的生物等效性。
方法 本研究按单中心、随机、开放、四周期交叉设计，共入组72名健康受试者，包括空腹组与餐后组各纳入36例健康受试者，在每周期给药当天口服受试制剂（T）或参比制剂（R）各1片（10 mg/10 mg），清洗期8天。用高效液相色谱串联质谱（LC-MS/MS）法测定血浆中游离依折麦布、总依折麦布（游离依折麦布+依折麦布葡萄糖苷酸结合物）和阿托伐他汀的浓度，用Phoenix WinNonlin 8.2软件分析药代动力学参数，并进行生物等效性评价。
结果 受试者服用两制剂后，空腹组血浆中有效成分的药代动力学参数如下：依折麦布的受试制剂和参比制剂药动学参数Cmax分别为（6.35±3.22）和（7.04±3.20）ng·mL-1；AUC0-t分别为（107.10±46.61）和（109.67±50.23）ng·h·mL-1；AUC0-∞分别为（114.88±49.96）和（117.14±50.74）ng·h·mL-1。Cmax、AUC0-t和AUC0-∞的几何均值比的90%置信区间分别为84.11%~98.34%、94.60%~106.44%和93.52%~105.82%，均在80.00%~125.00%。总依折麦布的受试制剂和参比制剂药动学参数Cmax分别为（67.01±35.70）和（71.82±30.91）ng·mL-1；AUC0-t分别为（605.29±255.51）和（615.90±270.21）ng·h·mL-1；AUC0-∞分别为（655.81±268.02）和（676.04±279.18）ng·h·mL-1。Cmax、AUC0-t和AUC0-∞的几何均值比的90%置信区间分别为85.32%~97.52%、92.35%~103.46%和91.43%~102.13%，均在80.00%~125.00%。阿托伐他汀的受试制剂和参比制剂药动学参数Cmax分别为（4.28±2.50）和（4.06±2.40）ng·mL-1；AUC0-t分别为（24.24±18.91）和（22.12±10.80）ng·h·mL-1；AUC0-∞分别为（23.86±12.05）和（23.44±10.98）ng·h·mL-1。阿托伐他汀Cmax的单侧95%置信上限<0、GMR值为1.06，在0.80~1.25内。AUC0-t、AUC0-∞几何均值比的90%置信区间分别为97.11%~109.14%和97.24%~104.00%，均在80.00%~125.00%。餐后组血浆中有效成分的药代动力学参数如下：依折麦布的受试制剂和参比制剂药动学参数Cmax分别为（12.50±8.43）和（12.10±10.20）ng·mL-1；AUC0-t分别为（115.66±61.86）和（114.91±61.10）ng·h·mL-1；AUC0-∞分别为（127.40±66.49）和（128.37±66.73）ng·h·mL-1。依折麦布Cmax的单侧95%置信上限<0、GMR值为1.09，在0.80~1.25内。AUC0-t和AUC0-∞几何均值比的90%置信区间分别为93.63%~107.27%和91.07%~108.13%，均在80.00%~125.00%。总依折麦布的受试制剂和参比制剂药动学参数Cmax分别为（102.02±50.21）和（95.10±48.31）ng·mL-1；AUC0-t分别为（660.62±342.67）和（645.43±290.84）ng·h·mL-1；AUC0-∞分别为（728.80±356.15）和（711.88±301.04）ng·h·mL-1。总依折麦布Cmax的单侧95%置信上限<0、GMR值为1.08，在0.80~1.25内。AUC0-t和AUC0-∞几何均值比的90%置信区间分别为95.12%~106.95%和95.27%~107.60%，均在80.00%~125.00%。阿托伐他汀的受试制剂和参比制剂药动学参数Cmax分别为（1.79±0.80）和（1.83±0.87）ng·mL-1；AUC0-t分别为（19.09±6.85）和（18.24±6.29）ng·h·mL-1；AUC0-∞分别为（21.25±6.97）和（20.34±6.84）ng·h·mL-1。Cmax、AUC0-t和AUC0-∞几何均值比的90%置信区间分别为91.25%~106.96%、99.81%~108.09%和100.22%~108.73%，均在80.00%~125.00%。
结论 依折麦布阿托伐他汀钙片受试制剂与参比制剂在空腹及餐后条件下，均具有生物等效性。
, authors=孙金菊
1, 芦霜
1, 李红云
1, 李秀敏
1, 苏建树
2, 陈钢
3, 郭瑞臣
4, 苏华
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孙金菊（1983-），女，副主任药师，主要从事Ⅰ期和生物等效性临床试验相关的研究和工作
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