Article(id=1291704812291252295, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704771212234905, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.17.019, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1741536000000, receivedDateStr=2025-03-10, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896025954, onlineDateStr=2026-08-05, pubDate=1758038400000, pubDateStr=2025-09-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896025954, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896025954, creator=13701087609, updateTime=1785896025954, updator=13701087609, issue=Issue{id=1291704771212234905, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='17', pageStart='2401', pageEnd='2550', issueExtLink='null', onlineDate='null', pubDate='1758038400000', pubDateStr='2025-09-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896016147, creator='13701087609', updateTime=1785896900366, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291708479866164175, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704771212234905, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291708479866164176, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704771212234905, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2510, endPage=2515, ext={EN=ArticleExt(id=1291704814333878344, articleId=1291704812291252295, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Bioequivalence of bisoprolol-amlodipine tablet in healthy volunteers, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective Evaluate whether the test formulation and reference formulation of bisoprolol amlodipine tablets are bioequivalent after a single oral administration in healthy subjects under fasting and postprandial conditions.
Methods A single-dose, randomized, open-label, two-period, self-crossover trial design was adopted. Fasting and postprandial tests were randomly divided into 2 administration sequence groups according to 1∶1 ratio, the subjects were administered orally one tablet of either the test or reference formulation of the bisoprolol-amlodipine tablet, containing 5 mg bisoprolol fumarate and 5 mg amlodipine besylate (equivalent to 5 mg amlodipine). Liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) was applied to determine the concentration of bisoprolol and amlodipine in plasma of healthy subjects after fasting or fed administration, while Phoenix WinNonlin 8.1 software were used for pharmacokinetics (PK) parameters calculation and bioequivalence analysis.
Results Healthy subjects took one tablet of test product (T) and the reference product (R), under fasting condition. The main pharmacokinetic parameters of bisoprolol were as follows: Cmax were (26.94±5.93) and (27.85±6.06) ng·mL-1, respectively; AUC0-t were (325.81±59.30) and (345.77±87.04) ng·mL-1·h-1, respectively; AUC0→∞ were (337.94±63.91) and (360.03±95.94) ng·mL-1·h-1, respectively; the main pharmacokinetic parameters of amlodipine were as follows: Cmax were (3.56±0.89) and (3.63±0.93) ng·mL-1, respectively; AUC0-t were (165.78±47.60) and (170.76±48.63) ng·mL-1·h-1, respectively; AUC0→∞ were (188.76±67.62) and (188.40±54.85) ng·mL-1·h-1, respectively; the 90% confidence intervals of Cmax、AUC0-t and AUC0-∞ after logarithmic conversion of bisoprolol and amlodipine of the two products were all within 80.00%-125.00%. Healthy subjects took the test and reference product under fed condition. The main pharmacokinetic parameters of bisoprolol were as follows: Cmax were (22.66±2.91) and (22.68±3.85) ng·mL-1, respectively; AUC0-t were (310.42±59.44) and (303.39±53.21) ng·mL-1·h-1, respectively; AUC0→∞ were (320.68±67.30) and (313.31±60.15) ng·mL-1·h-1, respectively; the main pharmacokinetic parameters of amlodipine were as follows: Cmax were (3.24±0.53) and (3.15±0.55) ng·mL-1, respectively; AUC0-t were (180.74±40.77) and (178.27±33.53) ng·mL-1·h-1, respectively; AUC0→∞ were (199.02±50.12) and (197.77±39.64) ng·mL-1·h-1, respectively. The 90% confidence intervals of Cmax、AUC0-t and AUC0-∞ after logarithmic conversion of bisoprolol and amlodipine of the two products were all within 80.00%-125.00%.
Conclusion Healthy adult subjects demonstrate bioequivalence between the test formulation and reference formulation of bisoprolol amlodipine tablets following a single oral administration under both fasting and postprandial conditions.
, authors=Yi-ting HU
1, Zi-wei SUI
2, Cai-yun JIA
1, Yu-fang XU
1, Hao-jing SONG
1, Na ZHAO
1, Hui-zhen WU
1, Wan-jun BAI
1, authorsList=Yi-ting HU, Zi-wei SUI, Cai-yun JIA, Yu-fang XU, Hao-jing SONG, Na ZHAO, Hui-zhen WU, Wan-jun BAI, authorCompany=null, correspAuthors=Hui-zhen WU, Wan-jun BAI, 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=1291704820176543818, articleId=1291704812291252295, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=比索洛尔氨氯地平片在健康受试者体内的生物等效性研究, 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 评估健康受试者在空腹及餐后状态下，单次口服比索洛尔氨氯地平片受试制剂与参比制剂是否具有生物等效性。
方法 按照单剂量、随机、开放、二周期、自身交叉、临床试验方法设计。在空腹与餐后试验中，受试者按1∶1比例随机分配至2个给药序列组，分别服用受试制剂或参比制剂各1片，每片受试制剂和参比制剂均含富马酸比索洛尔5 mg和苯磺酸氨氯地平（按氨氯地平计）5 mg，用液相色谱串联质谱法测定给药后血浆中比索洛尔和氨氯地平的药物浓度，用Phoenix WinNonlin 8.1软件进行药代动力学参数计算及生物等效性评价。
结果 受试者单次空腹口服受试制剂和参比制剂后，比索洛尔的主要药代动力学参数如下：Cmax分别为（26.94±5.93）和（27.85±6.06）ng·mL-1，AUC0-t分别为（325.81±59.30）和（345.77±87.04）ng·mL-1·h-1，AUC0→∞分别为（337.94±63.91）和（360.03±95.94）ng·mL-1·h-1；氨氯地平的主要药代动力学参数如下：Cmax分别为（3.56±0.89）和（3.63±0.93）ng·mL-1，AUC0-t分别为（165.78±47.60）和（170.76±48.63）ng·mL-1·h-1，AUC0→∞分别为（188.76±67.62）和（188.40±54.85）ng·mL-1·h-1。2种制剂比索洛尔和氨氯地平的Cmax、AUC0-t和AUC0-∞经对数转换后的90%置信区间均在80.00%~125.00%内。受试者单次餐后口服受试制剂和参比制剂后，比索洛尔的主要药代动力学参数如下：Cmax分别为（22.66±2.91）和（22.68±3.85）ng·mL-1，AUC0-t分别为（310.42±59.44）和（303.39±53.21）ng·mL-1·h-1，AUC0→∞分别为（320.68±67.30）和（313.31±60.15）ng·mL-1·h-1；氨氯地平的主要药代动力学参数如下：Cmax分别为（3.24±0.53）和（3.15±0.55）ng·mL-1，AUC0-t分别为（180.74±40.77）和（178.27±33.53）ng·mL-1·h-1，AUC0→∞分别为（199.02±50.12）和（197.77±39.64）ng·mL-1·h-1。2种制剂比索洛尔和氨氯地平的Cmax、AUC0-t和AUC0-∞经对数转换后的90%置信区间均在80.00%~125.00%内。
结论 在空腹与餐后状态下，单次口服比索洛尔氨氯地平片的受试制剂与参比制剂在健康成人中呈现生物等效性。
, authors=胡义亭
1, 眭紫薇
2, 贾彩云
1, 许玉芳
1, 宋浩静
1, 赵娜
1, 吴惠珍
1, 白万军
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胡义亭（1972-），女，主任医师，主要从事药物临床试验及临床药理研究方面的工作
眭紫薇，女，中级工程师，主要从事药物临床试验方面的工作
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