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Article(id=1291404599517237664, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404554201985968, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.06.019, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1728489600000, receivedDateStr=2024-10-10, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824449662, onlineDateStr=2026-08-04, pubDate=1743091200000, pubDateStr=2025-03-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824449662, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824449662, creator=13701087609, updateTime=1785824449662, updator=13701087609, issue=Issue{id=1291404554201985968, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='6', pageStart='751', pageEnd='900', issueExtLink='null', onlineDate='null', pubDate='1743091200000', pubDateStr='2025-03-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824438858, creator='13701087609', updateTime=1785824438858, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=852, endPage=856, ext={EN=ArticleExt(id=1291404599836004769, articleId=1291404599517237664, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Bioequivalence study of rotigotine patches 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 rotigotine patches after a single dose in healthy Chinese subjects.

Methods

Using randomized, open, fasting, single-dose, two-preparation, four-cycle, two-sequence exact repeat crossover design, 24 healthy subjects applied one of the test preparation or reference preparation (4.5 mg·10 cm-2) to the abdominal skin. To determine the drug concentration in human plasma by liquid chromatography-tandem mass spectrometry. Pharmacokinetic software was used to calculate the relevant pharmacokinetic parameters, and the bioequivalence evaluation was carried out.

Results

The Cmax of the test preparation and the reference preparation of rotigotine patches were (275.04±98.93) and (277.11±96.78) pg·mL-1, the AUC0-t were (5 011.91±2 015.32) and (4 934.28±2 095.76) h·pg·mL-1, the AUC0-∞ were (5 092.68±2 033.23) and (5 160.61±2 052.04) h·pg·mL-1, respectively. Cmax, AUC0-t and AUC0-∞ geometric mean (90% confidence interval) were all in the equivalent interval of 80.00%-125.00%.

Conclusion

The test preparation and reference preparation of rotigotine patches are bioequivalent in healthy Chinese subjects.

, authors=Min-sheng JIANG1, 2, Xian-miao YIN1, 2, Qi-tao ZHU1, 2, Yu HUA1, 2, Huan SONG1, 2, Feng DING1, 2, Dong-sheng GUO1, Fang-liang GAN1, authorsList=Min-sheng JIANG, Xian-miao YIN, Qi-tao ZHU, Yu HUA, Huan SONG, Feng DING, Dong-sheng GUO, Fang-liang GAN, authorCompany=null, correspAuthors=Fang-liang GAN, 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=1291404600737780130, articleId=1291404599517237664, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=罗替高汀贴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

评价罗替高汀贴片在中国健康受试者体内单次给药后的生物等效性。

方法

用随机、开放、空腹、单剂量、两制剂、四周期、两序列完全重复交叉设计，24例健康受试者于腹部皮肤帖用4.5 mg·10 cm-2受试制剂或参比制剂。用液相色谱-串联质谱法测定人血浆中药物浓度，用药代动力学软件计算相关药代动力学参数，并对其进行生物等效性评价。

结果

罗替高汀贴片的受试制剂和参比制剂的Cmax分别为（275.04±98.93）和（277.11±96.78）pg·mL-1，AUC0-t分别为（5 011.91±2 015.32）和（4 934.28±2 095.76）h·pg·mL-1，AUC0-∞分别为（5 092.68±2 033.23）和（5 160.61±2 052.04）h·pg·mL-1，Cmax、AUC0-t和AUC0-∞几何均值均在80.00%～125.00%等效区间。

结论

罗替高汀贴片受试制剂和参比制剂在中国健康受试者体内具有生物等效性。

, authors=姜敏生1, 2, 尹咸淼1, 2, 朱琦涛1, 2, 华玉1, 2, 宋欢1, 2, 丁峰1, 2, 郭东生1, 甘方良1, authorsList=姜敏生, 尹咸淼, 朱琦涛, 华玉, 宋欢, 丁峰, 郭东生, 甘方良, authorCompany=null, correspAuthors=甘方良, authorNote=

姜敏生（1998-），女，硕士研究生，主要从事临床药代动力学方面的研究

, correspAuthorsNote=
甘方良，主任药师，硕士生导师 MP: 13387170096 E-mail:
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姜敏生（1998-），女，硕士研究生，主要从事临床药代动力学方面的研究

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罗替高汀贴片在中国健康受试者中的生物等效性研究
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姜敏生 1, 2 , 尹咸淼 1, 2 , 朱琦涛 1, 2 , 华玉 1, 2 , 宋欢 1, 2 , 丁峰 1, 2 , 郭东生 1 , 甘方良 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(6): 852-856
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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 (6) : 852 -856
罗替高汀贴片在中国健康受试者中的生物等效性研究
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姜敏生1, 2, 尹咸淼1, 2, 朱琦涛1, 2, 华玉1, 2, 宋欢1, 2, 丁峰1, 2, 郭东生1, 甘方良1
作者信息
  • 1.咸宁市中心医院 临床药理机构办公室，湖北 咸宁 437100
  • 2.湖北科技学院 医学部 药学院，湖北 咸宁 437100
通讯作者:
甘方良，主任药师，硕士生导师 MP: 13387170096 E-mail:
作者简介:

姜敏生（1998-），女，硕士研究生，主要从事临床药代动力学方面的研究

Bioequivalence study of rotigotine patches in healthy Chinese subjects
Min-sheng JIANG1, 2, Xian-miao YIN1, 2, Qi-tao ZHU1, 2, Yu HUA1, 2, Huan SONG1, 2, Feng DING1, 2, Dong-sheng GUO1, Fang-liang GAN1
Affiliations
  • 1.Office of Clinical Pharmacology, Xianning Central Hospital, Xianning 437100, Hubei Province, China
  • 2.School of Pharmacy, Faculty of Medicine, Hubei University of Science and Technology, Xianning 437100, Hubei Province, China
出版时间: 2025-03-28 doi: 10.13699/j.cnki.1001-6821.2025.06.019
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摘要
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目的

评价罗替高汀贴片在中国健康受试者体内单次给药后的生物等效性。

方法

用随机、开放、空腹、单剂量、两制剂、四周期、两序列完全重复交叉设计，24例健康受试者于腹部皮肤帖用4.5 mg·10 cm-2受试制剂或参比制剂。用液相色谱-串联质谱法测定人血浆中药物浓度，用药代动力学软件计算相关药代动力学参数，并对其进行生物等效性评价。

结果

罗替高汀贴片的受试制剂和参比制剂的Cmax分别为（275.04±98.93）和（277.11±96.78）pg·mL-1，AUC0-t分别为（5 011.91±2 015.32）和（4 934.28±2 095.76）h·pg·mL-1，AUC0-∞分别为（5 092.68±2 033.23）和（5 160.61±2 052.04）h·pg·mL-1，Cmax、AUC0-t和AUC0-∞几何均值均在80.00%～125.00%等效区间。

结论

罗替高汀贴片受试制剂和参比制剂在中国健康受试者体内具有生物等效性。

罗替高汀贴片  /  液相色谱－串联质谱法  /  药代动力学  /  生物等效性
Objective

To evaluate the bioequivalence of rotigotine patches after a single dose in healthy Chinese subjects.

Methods

Using randomized, open, fasting, single-dose, two-preparation, four-cycle, two-sequence exact repeat crossover design, 24 healthy subjects applied one of the test preparation or reference preparation (4.5 mg·10 cm-2) to the abdominal skin. To determine the drug concentration in human plasma by liquid chromatography-tandem mass spectrometry. Pharmacokinetic software was used to calculate the relevant pharmacokinetic parameters, and the bioequivalence evaluation was carried out.

Results

The Cmax of the test preparation and the reference preparation of rotigotine patches were (275.04±98.93) and (277.11±96.78) pg·mL-1, the AUC0-t were (5 011.91±2 015.32) and (4 934.28±2 095.76) h·pg·mL-1, the AUC0-∞ were (5 092.68±2 033.23) and (5 160.61±2 052.04) h·pg·mL-1, respectively. Cmax, AUC0-t and AUC0-∞ geometric mean (90% confidence interval) were all in the equivalent interval of 80.00%-125.00%.

Conclusion

The test preparation and reference preparation of rotigotine patches are bioequivalent in healthy Chinese subjects.

rotigotine patches  /  liquid chromatography-tandem mass spectrometry  /  pharmacokinetic  /  bioequivalence
姜敏生, 尹咸淼, 朱琦涛, 华玉, 宋欢, 丁峰, 郭东生, 甘方良. 罗替高汀贴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 (6) : 852 -856 . DOI: 10.13699/j.cnki.1001-6821.2025.06.019
Min-sheng JIANG, Xian-miao YIN, Qi-tao ZHU, Yu HUA, Huan SONG, Feng DING, Dong-sheng GUO, Fang-liang GAN. Bioequivalence study of rotigotine patches in healthy Chinese subjects[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (6) : 852 -856 . DOI: 10.13699/j.cnki.1001-6821.2025.06.019

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doi: 10.13699/j.cnki.1001-6821.2025.06.019
  • 接收时间：2024-10-10
  • 首发时间：2026-08-04
  • 出版时间：2025-03-28
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  • 收稿日期：2024-10-10
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    1.咸宁市中心医院 临床药理机构办公室，湖北 咸宁 437100
    2.湖北科技学院 医学部 药学院，湖北 咸宁 437100

通讯作者:

甘方良，主任药师，硕士生导师 MP: 13387170096 E-mail:
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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2025.06.019
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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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