中国临床药理学杂志2025，Vol.41Issue(6)：852-856,5.DOI:10.13699/j.cnki.1001-6821.2025.06.019
罗替高汀贴片在中国健康受试者中的生物等效性研究
Bioequivalence study of rotigotine patches in healthy Chinese subjects
姜敏生 1尹咸淼 1朱琦涛 1华玉 1宋欢 1丁峰 1郭东生 2甘方良2
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||湖北科技学院医学部药学院,湖北咸宁 437100
- 2. 咸宁市中心医院临床药理机构办公室,湖北咸宁 437100
- 折叠
摘要
Abstract
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(5011.91±2015.32)and(4934.28±2 095.76)h·pg·mL-1,the AUC0-∞ were(5092.68±2033.23)and(5160.61±2052.04)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.关键词
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Key words
rotigotine patches/liquid chromatography-tandem mass spectrometry/pharmacokinetic/bioequivalence分类
医药卫生引用本文复制引用
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[J].中国临床药理学杂志,2025,41(6):852-856,5.
