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Article(id=1291339043439108590, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291339021272211834, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.02.014, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1719676800000, receivedDateStr=2024-06-30, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785808819874, onlineDateStr=2026-08-04, pubDate=1737993600000, pubDateStr=2025-01-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785808819874, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785808819874, creator=13041195026, updateTime=1785808819874, updator=13041195026, issue=Issue{id=1291339021272211834, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='2', pageStart='151', pageEnd='300', issueExtLink='null', onlineDate='null', pubDate='1737993600000', pubDateStr='2025-01-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785808814590, creator='13041195026', updateTime=1785808814590, updator='13041195026', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=220, endPage=224, ext={EN=ArticleExt(id=1291339043661406703, articleId=1291339043439108590, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Bioequivalence study of desloratadine 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 explore the pharmacokinetic (PK) characteristics of desloratadine tablets and reference drugs in healthy subjects, and evaluate their bioequivalence and safety.

Methods

The random, open, two-period, cross-over pharmacokinetic study method was adopted, each subject received a single oral dose of desloratadine tablets test drug(T) or reference drug(R) for 5 mg. The concentrations of desloratadine and 3-hydroxy desloratadine in plasma were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS); and the PK parameters were calculated by WinNonlin 8.1 software to evaluate the bioequivalence.

Results

The main PK parameters of T and R of desloratadine were as follows: the fasting condition Cmax were respectively (3 809.82±1 016.54) and (3 642.36±777.07) pg·mL-1; AUC0-120h were respectively (5.75×104±5.03×104) and (5.51×104±4.00×104) pg·h·mL-1; AUC0-∞ were respectively (6.85×104±1.03×104) and (6.37×104±7.92×104) pg·h·mL-1. The fed condition Cmax were respectively (4 398.98±1 191.22) and (4 744.40±1 511.97) pg·mL-1; AUC0-120 h were respectively(5.25×104±1.82×104) and (5.55×104±1.98×104) pg·h·mL-1; AUC0-∞ were respectively(5.37×104±1.86×104) and (5.68×104±2.04×104) pg·h·mL-1. The 90% confidence interval of Cmax, AUC0-t and AUC0-∞ of desloratadine were all within 80.00%~125.00%.

Conclusion

There was no significant difference in the main PK parameters between T and R under fasting or high-fat postprandial conditions, and desloratadine tablets were bioequivalent, safe and well tolerated.

, authors=Peng-fei XIE1, Yuan-lu CHEN1, Hong-di CUI1, Hui LONG1, Yong-gang ZHAO1, Qi-shan HUANG2, Peng YANG3, Yan ZHOU3, Yong-dong ZHANG1, authorsList=Peng-fei XIE, Yuan-lu CHEN, Hong-di CUI, Hui LONG, Yong-gang ZHAO, Qi-shan HUANG, Peng YANG, Yan ZHOU, Yong-dong ZHANG, authorCompany=null, correspAuthors=Yong-dong ZHANG, 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=1291339045729198576, articleId=1291339043439108590, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=地氯雷他定片在中国健康受试者的等效性研究, 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

探究地氯雷他定片受试制剂与参比药物在健康受试者中药代动力学（PK）特征，并评价其生物等效性及安全性。

方法

用随机、开放、两周期交叉设计，受试者空腹或高脂餐后单次口服地氯雷他定片受试制剂或参比药物5 mg，用液质联用技术（LC-MS/MS）检测和分析受试者血浆样品中地氯雷他定及代谢物3-羟基地氯雷他定的浓度，并经统计分析软件WinNonLin8.1计算和分析地两制剂主要药代动力学参数，评价其生物等效性。

结果

空腹试验地氯雷他定片受试制剂与参比药物的主要PK指标：地氯雷他定的Cmax分别为（3 809.82±1 016.54）和（3 642.36±777.07）pg·mL-1；AUC0-120 h分别为（5.75×104±5.03×104）和（5.51×104±4.00×104）pg·h·mL-1；AUC0-∞分别为（6.85×104±1.03×104）和（6.37×104±7.92×104）pg·h·mL-1。餐后试验地氯雷他定片受试制剂与参比药物的主要PK指标：地氯雷他定的Cmax分别为（4 398.98±1 191.22）和（4 744.40±1 511.97）pg·mL-1；AUC0-120 h分别为（5.25×104±1.82×104）和（5.55×104±1.98×104）pg·h·mL-1；AUC0-∞分别为（5.37×104±1.86×104）和（5.68×104±2.04×104）pg·h·mL-1。空腹试验和餐后试验地氯雷他定的Cmax、AUC0-t、AUC0-∞的几何均值比值（GMR，T/R）及其90%置信区间的统计结果均在80.00%~125.00%内。

结论

空腹或高脂餐后条件下，地氯雷他定片受试制剂与参比药物的主要药代动力学参数无明显差异，具有生物等效性，且安全性及耐受性良好。

, authors=谢朋飞1, 陈元璐1, 崔宏娣1, 龙辉1, 赵永刚1, 黄启山2, 杨鹏3, 周燕3, 张永东1, authorsList=谢朋飞, 陈元璐, 崔宏娣, 龙辉, 赵永刚, 黄启山, 杨鹏, 周燕, 张永东, authorCompany=null, correspAuthors=张永东, authorNote=

谢朋飞（1985-），男，副主任药师，主要从事药物临床试验及临床药学的相关工作

, correspAuthorsNote=
张永东，副主任药师 Tel: （0735）2343073 E-mail:
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谢朋飞（1985-），男，副主任药师，主要从事药物临床试验及临床药学的相关工作

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谢朋飞（1985-），男，副主任药师，主要从事药物临床试验及临床药学的相关工作

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地氯雷他定片在中国健康受试者的等效性研究
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谢朋飞 1 , 陈元璐 1 , 崔宏娣 1 , 龙辉 1 , 赵永刚 1 , 黄启山 2 , 杨鹏 3 , 周燕 3 , 张永东 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(2): 220-224
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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 (2) : 220 -224
地氯雷他定片在中国健康受试者的等效性研究
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谢朋飞1, 陈元璐1, 崔宏娣1, 龙辉1, 赵永刚1, 黄启山2, 杨鹏3, 周燕3, 张永东1
作者信息
  • 1.郴州市第一人民医院 Ⅰ期临床研究室，湖南 郴州 423000
  • 2.安徽门捷科技发展有限公司，安徽 合肥 230601
  • 3.安徽万邦医药科技股份有限公司，安徽 合肥 230000
通讯作者:
张永东，副主任药师 Tel: （0735）2343073 E-mail:
作者简介:

谢朋飞（1985-），男，副主任药师，主要从事药物临床试验及临床药学的相关工作

Bioequivalence study of desloratadine tablets in healthy Chinese subjects
Peng-fei XIE1, Yuan-lu CHEN1, Hong-di CUI1, Hui LONG1, Yong-gang ZHAO1, Qi-shan HUANG2, Peng YANG3, Yan ZHOU3, Yong-dong ZHANG1
Affiliations
  • 1.Phase Ⅰ Clinical Centre, Chenzhou No.1 People’s Hospital, Chenzhou 423000, Hunan Province, China
  • 2.Anhui Menjie Technology Development Co., Ltd, Hefei 230601, Anhui Province, China
  • 3.Anhui Wanbang Pharmaceutical Technology Co., Ltd, Hefei 230000, Anhui Province, China
出版时间: 2025-01-28 doi: 10.13699/j.cnki.1001-6821.2025.02.014
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摘要
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目的

探究地氯雷他定片受试制剂与参比药物在健康受试者中药代动力学（PK）特征，并评价其生物等效性及安全性。

方法

用随机、开放、两周期交叉设计，受试者空腹或高脂餐后单次口服地氯雷他定片受试制剂或参比药物5 mg，用液质联用技术（LC-MS/MS）检测和分析受试者血浆样品中地氯雷他定及代谢物3-羟基地氯雷他定的浓度，并经统计分析软件WinNonLin8.1计算和分析地两制剂主要药代动力学参数，评价其生物等效性。

结果

空腹试验地氯雷他定片受试制剂与参比药物的主要PK指标：地氯雷他定的Cmax分别为（3 809.82±1 016.54）和（3 642.36±777.07）pg·mL-1；AUC0-120 h分别为（5.75×104±5.03×104）和（5.51×104±4.00×104）pg·h·mL-1；AUC0-∞分别为（6.85×104±1.03×104）和（6.37×104±7.92×104）pg·h·mL-1。餐后试验地氯雷他定片受试制剂与参比药物的主要PK指标：地氯雷他定的Cmax分别为（4 398.98±1 191.22）和（4 744.40±1 511.97）pg·mL-1；AUC0-120 h分别为（5.25×104±1.82×104）和（5.55×104±1.98×104）pg·h·mL-1；AUC0-∞分别为（5.37×104±1.86×104）和（5.68×104±2.04×104）pg·h·mL-1。空腹试验和餐后试验地氯雷他定的Cmax、AUC0-t、AUC0-∞的几何均值比值（GMR，T/R）及其90%置信区间的统计结果均在80.00%~125.00%内。

结论

空腹或高脂餐后条件下，地氯雷他定片受试制剂与参比药物的主要药代动力学参数无明显差异，具有生物等效性，且安全性及耐受性良好。

地氯雷他定片  /  中国健康受试者  /  药代动力学  /  生物等效性
Objective

To explore the pharmacokinetic (PK) characteristics of desloratadine tablets and reference drugs in healthy subjects, and evaluate their bioequivalence and safety.

Methods

The random, open, two-period, cross-over pharmacokinetic study method was adopted, each subject received a single oral dose of desloratadine tablets test drug(T) or reference drug(R) for 5 mg. The concentrations of desloratadine and 3-hydroxy desloratadine in plasma were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS); and the PK parameters were calculated by WinNonlin 8.1 software to evaluate the bioequivalence.

Results

The main PK parameters of T and R of desloratadine were as follows: the fasting condition Cmax were respectively (3 809.82±1 016.54) and (3 642.36±777.07) pg·mL-1; AUC0-120h were respectively (5.75×104±5.03×104) and (5.51×104±4.00×104) pg·h·mL-1; AUC0-∞ were respectively (6.85×104±1.03×104) and (6.37×104±7.92×104) pg·h·mL-1. The fed condition Cmax were respectively (4 398.98±1 191.22) and (4 744.40±1 511.97) pg·mL-1; AUC0-120 h were respectively(5.25×104±1.82×104) and (5.55×104±1.98×104) pg·h·mL-1; AUC0-∞ were respectively(5.37×104±1.86×104) and (5.68×104±2.04×104) pg·h·mL-1. The 90% confidence interval of Cmax, AUC0-t and AUC0-∞ of desloratadine were all within 80.00%~125.00%.

Conclusion

There was no significant difference in the main PK parameters between T and R under fasting or high-fat postprandial conditions, and desloratadine tablets were bioequivalent, safe and well tolerated.

desloratadine tablet  /  healthy Chinese subject  /  pharmacokinetic  /  bioequivalence
谢朋飞, 陈元璐, 崔宏娣, 龙辉, 赵永刚, 黄启山, 杨鹏, 周燕, 张永东. 地氯雷他定片在中国健康受试者的等效性研究. 中国临床药理学杂志, 2025 , 41 (2) : 220 -224 . DOI: 10.13699/j.cnki.1001-6821.2025.02.014
Peng-fei XIE, Yuan-lu CHEN, Hong-di CUI, Hui LONG, Yong-gang ZHAO, Qi-shan HUANG, Peng YANG, Yan ZHOU, Yong-dong ZHANG. Bioequivalence study of desloratadine tablets in healthy Chinese subjects[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (2) : 220 -224 . DOI: 10.13699/j.cnki.1001-6821.2025.02.014
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  • 郴州市科技发展计划基金资助项目(yfzx201912)
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2025年第41卷第2期
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doi: 10.13699/j.cnki.1001-6821.2025.02.014
  • 接收时间：2024-06-30
  • 首发时间：2026-08-04
  • 出版时间：2025-01-28
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  • 收稿日期：2024-06-30
基金
郴州市科技发展计划基金资助项目(yfzx201912)
作者信息
    1.郴州市第一人民医院 Ⅰ期临床研究室，湖南 郴州 423000
    2.安徽门捷科技发展有限公司，安徽 合肥 230601
    3.安徽万邦医药科技股份有限公司，安徽 合肥 230000

通讯作者:

张永东，副主任药师 Tel: （0735）2343073 E-mail:
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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2025.02.014
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2种不同金属材料的力学参数
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Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
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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