中国临床药理学杂志2024，Vol.40Issue(17)：2548-2551,4.DOI:10.13699/j.cnki.1001-6821.2024.17.019
卡托普利片在中国健康受试者中的生物等效性研究
Study on the bioequivalence of captopril tablets in Chinese healthy subjects
何亚青 1张望刚 1刘彩霞 2李昕遥 3李金姑4
作者信息
- 1. 浙江医院,Ⅰ期临床试验研究室,浙江杭州 310000
- 2. 浙江医院,护理部,浙江杭州 310000
- 3. 浙江医院,心内科,浙江杭州 310000
- 4. 中孚药业股份有限公司,山东潍坊 261000
- 折叠
摘要
Abstract
Objective To compare the pharmacokinetic behavior of two captopril tablets in Chinese healthy subjects,and evaluate the bioequivalence and safety of the tested and reference preparations.Methods This study was a single-center,random,open,double-cycle,double-cross design scheme.Twenty-four healthy subjects were randomized divided two groups and took single dose of 25 mg captopril of test tablet or reference tablet under fasting condition during each period.Plasma concentrations of captopril were determined by liquid chromatography-mass spectroscopy(LC-MS/MS)following administration of the oral single captopril tablet.The pharmacokinetic parameters were calculated by using non-atrioventricular model with WinNonlin 8.0 software to evaluate bioequivalence.The safety of clinical observation indexes of the subjects was evaluated during the trail.Results Main pharmacokinetic parameters of test preparation and reference preparation captopril in fasting group test:Cmax were(803.22±196.81)and(844.75±163.43)ng·mL-1;AUC0-t were(3 118.06±642.05)and(3 353.53±597.94)h·ng·mL-1;AUC0-∞ were(3 347.35±712.07)and(3 594.15±654.39)h·ng·mL-1.The 90％confidence intervals(CI)of geornetric mean ratio of Cmax,AUC0-t and AUC0-∞ were 87.15％-99.97％,89.54％-96.14％and 89.55％-96.26％,all in the range of 80.00％-125.00％,indicating that the bioequivalence of the two preparations could be determined.During the trial,the incidence rates of adverse events for the test preparation and the reference preparation were 30.43％and 33.33％,respectively,without any serious adverse events occurring.Conclusion The test tablet and reference tablet of captopril were equivalent and safe during the trial.关键词
卡托普利/生物等效性/药物动力学/安全性Key words
captopril/bioequivalent/pharmacokinetics/safety分类
药学引用本文复制引用
何亚青,张望刚,刘彩霞,李昕遥,李金姑..卡托普利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,2024,40(17):2548-2551,4.
