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Article(id=1291404955219390802, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404875351449891, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.09.017, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1734364800000, receivedDateStr=2024-12-17, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824534467, onlineDateStr=2026-08-04, pubDate=1747411200000, pubDateStr=2025-05-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824534467, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824534467, creator=13701087609, updateTime=1785824534467, updator=13701087609, issue=Issue{id=1291404875351449891, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='9', pageStart='1201', pageEnd='1350', issueExtLink='null', onlineDate='null', pubDate='1747411200000', pubDateStr='2025-05-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824515426, creator='13701087609', updateTime=1785824515426, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1299, endPage=1304, ext={EN=ArticleExt(id=1291404956628676948, articleId=1291404955219390802, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Bioequivalence study of diphenidol hydrochloride tablets in healthy Chinese subjects, columnId=1246531407389020354, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Pharmacokinetics and Bioequivalence Study, runingTitle=null, highlight=null, articleAbstract=
Objective

To evaluate the bioequivalence of test preparation (T) and reference preparation (R) of diphenidol hydrochloride tablets taken orally in a single fasting/postprandibular state in healthy Chinese subjects.

Methods

This protocol was designed as random, open, single-center, single-dose, double-cycle and double-cross experiment was selected in this study. A total of 66 healthy male and female subjects were enrolled, including 24 subjects in the test group and 42 subjects in the reference group. All subjects took the test preparation and the reference preparation 25 mg in each cycle. The plasma concentration of diphenidol hydrochloride was determined by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS), and the pharmacokinetic (PK) data collected was analyzed and processed statistically.

Results

The PK parameters of diphenidol hydrochloride tablets and reference preparations in fasting group were as follows: Cmax were (75.90±34.60) and (67.96±19.90) ng·mL-1, respectively; AUC0-t were (387.67±198.48) and (341.57±137.05) ng·h·mL-1, respectively; AUC0-∞ were (413.00±228.39) and (361.70±161.19) ng·h·mL-1, respectively. Main PK parameters of diphenidol hydrochloride tablets and reference preparations orally taken by subjects after meals: Cmax were (92.60±33.60) and (85.30±31.96) ng·mL-1, respectively; AUC0-t were (511.90±206.87) and (498.33±197.78) ng·h·mL-1, respectively; AUC0-∞ were (543.21±236.90) and (513.98±203.92) ng·h·mL-1, respectively. Under fasting and postprandial conditions, subjects took diphenidol hydrochloride tablet and reference preparation orally, one tablet 25 mg each time. The geometric mean of the main pharmacokinetic parameters of difenidol in plasma (Cmax, AUC0-t, AUC0-∞) and the ratio of their corresponding parameters ranged from 80.00% to 125.00% with 90% confidence interval, and no serious adverse events occurred in both groups.

Conclusion

Diphenidol hydrochloride tablets show bioequivalence and good safety evaluation under fasting and postprandial conditions

, authors=Xu ZHU1, 2, 3, 4, Ke-li WANG5, Xiao-ming ZHANG6, Xiao-ni WANG2, 3, 4, Jin-mei ZHOU2, 4, Ning CHEN2, 3, 4, Huan ZHOU2, 3, 4, Qing-fei WANG1, authorsList=Xu ZHU, Ke-li WANG, Xiao-ming ZHANG, Xiao-ni WANG, Jin-mei ZHOU, Ning CHEN, Huan ZHOU, Qing-fei WANG, authorCompany=null, correspAuthors=Qing-fei WANG, 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=1291404957257822550, articleId=1291404955219390802, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=盐酸地芬尼多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

评价中国健康受试者在单次空腹/餐后状态下口服盐酸地芬尼多片受试制剂（T）和参比制剂（R）的生物等效性。

方法

本方案按随机、开放、单中心、单次给药、双周期、双交叉设计，共入组66名健康男女受试者，包括受试组24名，参比组42名，受试者在每个周期内均服用受试制剂及参比制剂25 mg，用经过验证的高效液相色谱串联质谱（HPLC-MS/MS）法检测血浆中盐酸地芬尼多的血药浓度，对收集到的药代动力学（PK）参数数据进行统计分析和处理。

结果

空腹组盐酸地芬尼多片受试及参比制剂的主要PK参数：Cmax分别为（75.90±34.60）和（67.96±19.90）ng·mL-1，AUC0-t分别为（387.67±198.48）和（341.57±137.05）ng·h·mL-1，AUC0-∞分别为（413.00±228.39）和（361.70±161.19）ng·h·mL-1。受试者在餐后口服盐酸地芬尼多片受试制剂和参比制剂的主要PK参数：Cmax分别为（92.60±33.60）和（85.30±31.96）ng·mL-1，AUC0-t分别为（511.90±206.87）和（498.33±197.78）ng·h·mL-1，AUC0-∞分别为（543.21±236.90）和（513.98±203.92）ng·h·mL-1。空腹及餐后条件下，受试者口服盐酸地芬尼多片受试与参比制剂25 mg，其血浆中地芬尼多的主要PK参数（Cmax、AUC0-t、AUC0-∞）的几何均数与其对应参数比值的90%置信区间在80.00%～125.00%，2组均未发生严重不良事件。

结论

在空腹及餐后条件下，盐酸地芬尼多片呈现出生物等效性且安全性评价良好。

, authors=朱旭1, 2, 3, 4, 王可莉5, 张晓明6, 王小妮2, 3, 4, 周锦梅2, 4, 陈宁2, 3, 4, 周焕2, 3, 4, 汪庆飞1, authorsList=朱旭, 王可莉, 张晓明, 王小妮, 周锦梅, 陈宁, 周焕, 汪庆飞, authorCompany=null, correspAuthors=汪庆飞, authorNote=

朱旭（1999-），男，硕士研究生，主要从事临床药学方面的研究

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汪庆飞，男，副主任药师，硕士生导师 MP: 15155253827 E-mail:
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盐酸地芬尼多片在中国健康受试者中的生物等效性研究
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朱旭 1, 2, 3, 4 , 王可莉 5 , 张晓明 6 , 王小妮 2, 3, 4 , 周锦梅 2, 4 , 陈宁 2, 3, 4 , 周焕 2, 3, 4 , 汪庆飞 1
中国临床药理学杂志 | 药代动力学与生物等效性研究 2025,41(9): 1299-1304
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中国临床药理学杂志 |药代动力学与生物等效性研究 2025 , 41 (9) : 1299 -1304
盐酸地芬尼多片在中国健康受试者中的生物等效性研究
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3.蚌埠医科大学 药学院，安徽 蚌埠 233000
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朱旭1, 2, 3, 4, 王可莉5, 张晓明6, 王小妮2, 3, 4, 周锦梅2, 4, 陈宁2, 3, 4, 周焕2, 3, 4, 汪庆飞1
作者信息
  • 1.蚌埠医科大学 第二附属医院 药剂科，安徽 蚌埠 233000
  • 2.蚌埠医科大学 第一附属医院 国家药物临床试验机构，安徽 蚌埠 233000
  • 3.蚌埠医科大学 药学院，安徽 蚌埠 233000
  • 4.创新药物药学研究与临床评价安徽省学科共建重点实验室，安徽 蚌埠 233000
  • 5.南京杰宁医药科技有限公司，江苏 南京 211100
  • 6.江苏亚邦爱普森药业有限公司，江苏 盐城 224600
通讯作者:
汪庆飞，男，副主任药师，硕士生导师 MP: 15155253827 E-mail:
作者简介:

朱旭（1999-），男，硕士研究生，主要从事临床药学方面的研究

Bioequivalence study of diphenidol hydrochloride tablets in healthy Chinese subjects
Xu ZHU1, 2, 3, 4, Ke-li WANG5, Xiao-ming ZHANG6, Xiao-ni WANG2, 3, 4, Jin-mei ZHOU2, 4, Ning CHEN2, 3, 4, Huan ZHOU2, 3, 4, Qing-fei WANG1
Affiliations
  • 1.Department of Pharmacy, The Second Affiliated Hospital of Bengbu Medical University, Bengbu 233000, Anhui Province, China
  • 2.National Drug Clinical Trial Institution, The First Affiliated Hospital of Bengbu Medical University, Bengbu 233000, Anhui Province, China
  • 3.College of Pharmacy, Bengbu Medical University, Bengbu 233000, Anhui Province, China
  • 4.Key Laboratory of Pharmaceutical Research and Clinical Evaluation of Innovative Drugs of Anhui Province, Bengbu 233000, Anhui Province, China
  • 5.Nanjing Jening Pharmaceutical Technology Co., LTD, Nanjing 211100, Jiangsu Province, China
  • 6.Jiangsu Yabang Epen Pharmaceutical Co., LTD, Yancheng 224600, Jiangsu Province, China
出版时间: 2025-05-17 doi: 10.13699/j.cnki.1001-6821.2025.09.017
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摘要
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目的

评价中国健康受试者在单次空腹/餐后状态下口服盐酸地芬尼多片受试制剂（T）和参比制剂（R）的生物等效性。

方法

本方案按随机、开放、单中心、单次给药、双周期、双交叉设计，共入组66名健康男女受试者，包括受试组24名，参比组42名，受试者在每个周期内均服用受试制剂及参比制剂25 mg，用经过验证的高效液相色谱串联质谱（HPLC-MS/MS）法检测血浆中盐酸地芬尼多的血药浓度，对收集到的药代动力学（PK）参数数据进行统计分析和处理。

结果

空腹组盐酸地芬尼多片受试及参比制剂的主要PK参数：Cmax分别为（75.90±34.60）和（67.96±19.90）ng·mL-1，AUC0-t分别为（387.67±198.48）和（341.57±137.05）ng·h·mL-1，AUC0-∞分别为（413.00±228.39）和（361.70±161.19）ng·h·mL-1。受试者在餐后口服盐酸地芬尼多片受试制剂和参比制剂的主要PK参数：Cmax分别为（92.60±33.60）和（85.30±31.96）ng·mL-1，AUC0-t分别为（511.90±206.87）和（498.33±197.78）ng·h·mL-1，AUC0-∞分别为（543.21±236.90）和（513.98±203.92）ng·h·mL-1。空腹及餐后条件下，受试者口服盐酸地芬尼多片受试与参比制剂25 mg，其血浆中地芬尼多的主要PK参数（Cmax、AUC0-t、AUC0-∞）的几何均数与其对应参数比值的90%置信区间在80.00%～125.00%，2组均未发生严重不良事件。

结论

在空腹及餐后条件下，盐酸地芬尼多片呈现出生物等效性且安全性评价良好。

地芬尼多片  /  生物等效性  /  药代动力学  /  安全性
Objective

To evaluate the bioequivalence of test preparation (T) and reference preparation (R) of diphenidol hydrochloride tablets taken orally in a single fasting/postprandibular state in healthy Chinese subjects.

Methods

This protocol was designed as random, open, single-center, single-dose, double-cycle and double-cross experiment was selected in this study. A total of 66 healthy male and female subjects were enrolled, including 24 subjects in the test group and 42 subjects in the reference group. All subjects took the test preparation and the reference preparation 25 mg in each cycle. The plasma concentration of diphenidol hydrochloride was determined by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS), and the pharmacokinetic (PK) data collected was analyzed and processed statistically.

Results

The PK parameters of diphenidol hydrochloride tablets and reference preparations in fasting group were as follows: Cmax were (75.90±34.60) and (67.96±19.90) ng·mL-1, respectively; AUC0-t were (387.67±198.48) and (341.57±137.05) ng·h·mL-1, respectively; AUC0-∞ were (413.00±228.39) and (361.70±161.19) ng·h·mL-1, respectively. Main PK parameters of diphenidol hydrochloride tablets and reference preparations orally taken by subjects after meals: Cmax were (92.60±33.60) and (85.30±31.96) ng·mL-1, respectively; AUC0-t were (511.90±206.87) and (498.33±197.78) ng·h·mL-1, respectively; AUC0-∞ were (543.21±236.90) and (513.98±203.92) ng·h·mL-1, respectively. Under fasting and postprandial conditions, subjects took diphenidol hydrochloride tablet and reference preparation orally, one tablet 25 mg each time. The geometric mean of the main pharmacokinetic parameters of difenidol in plasma (Cmax, AUC0-t, AUC0-∞) and the ratio of their corresponding parameters ranged from 80.00% to 125.00% with 90% confidence interval, and no serious adverse events occurred in both groups.

Conclusion

Diphenidol hydrochloride tablets show bioequivalence and good safety evaluation under fasting and postprandial conditions

diphenidol tablet  /  bioequivalence  /  pharmacokinetics  /  safety
朱旭, 王可莉, 张晓明, 王小妮, 周锦梅, 陈宁, 周焕, 汪庆飞. 盐酸地芬尼多片在中国健康受试者中的生物等效性研究. 中国临床药理学杂志, 2025 , 41 (9) : 1299 -1304 . DOI: 10.13699/j.cnki.1001-6821.2025.09.017
Xu ZHU, Ke-li WANG, Xiao-ming ZHANG, Xiao-ni WANG, Jin-mei ZHOU, Ning CHEN, Huan ZHOU, Qing-fei WANG. Bioequivalence study of diphenidol hydrochloride tablets in healthy Chinese subjects[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (9) : 1299 -1304 . DOI: 10.13699/j.cnki.1001-6821.2025.09.017
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  • 安徽省中医药管理局基金资助项目(2024CCCX258)
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doi: 10.13699/j.cnki.1001-6821.2025.09.017
  • 接收时间：2024-12-17
  • 首发时间：2026-08-04
  • 出版时间：2025-05-17
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  • 收稿日期：2024-12-17
基金
安徽省中医药管理局基金资助项目(2024CCCX258)
作者信息
    1.蚌埠医科大学 第二附属医院 药剂科，安徽 蚌埠 233000
    2.蚌埠医科大学 第一附属医院 国家药物临床试验机构，安徽 蚌埠 233000
    3.蚌埠医科大学 药学院，安徽 蚌埠 233000
    4.创新药物药学研究与临床评价安徽省学科共建重点实验室，安徽 蚌埠 233000
    5.南京杰宁医药科技有限公司，江苏 南京 211100
    6.江苏亚邦爱普森药业有限公司，江苏 盐城 224600

通讯作者:

汪庆飞，男，副主任药师，硕士生导师 MP: 15155253827 E-mail:
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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2025.09.017
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2种不同金属材料的力学参数
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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