中国临床药理学杂志2026，Vol.42Issue(5)：700-705,6.DOI:10.13699/j.cnki.1001-6821.2026.05.016
阿戈美拉汀片在中国健康参与者中的生物等效性评价
Bioequivalence study of agomelatine tablets biosimilars in Chinese healthy volunteers
肖艳霞 1李若茗 1杨少杰 1杨贵刚 1裴莹子 2赵晓 2谭云龙 1陈松1
作者信息
- 1. 首都医科大学附属北京回龙观医院/北京大学回龙观临床医学院国家药物临床试验机构,北京 100096
- 2. 北京福元医药股份有限公司,北京 101100
- 折叠
摘要
Abstract
Objective To evaluate the safety and bioequivalence of two formulations of agomelatine tablets in healthy Chinese subjects.Methods A randomized,open-label,two-treatment,four-period,two-sequence,fully replicated crossover bioequivalence study was conducted under both fasting and fed conditions.Each subject received a single 25 mg dose of the test(T)product or reference(R)product agomelatine tablet in both fasting and fed conditions.Plasma concentration of agomelatine was determined by the liquid chromatography-tandem mass spectrometry(LC-MS/MS)method.The main pharmacokinetic parameters were derived using WinNonlin 8.3 software.Results A total of 128 subjects were enrolled,64 in the fasting group and 64 in the fed group.The primary pharmacokinetic(PK)parameters of the test and reference formulations under fasting condition were as follows:Cmax were(25.55±29.65)and(26.59±28.04)ng·mL-1,AUC0-t were(28.59±26.66)and(29.33±26.98)ng·h·mL-1,AUC0-∞ were(29.13±26.96)and(29.62±27.17)ng·h·mL-1.The primary pharmacokinetic parameters of the test and reference formulations under fed condition were as follows:Cmax were(26.26±23.29)and(28.97±34.82)ng·mL-1,AUC0-t were(35.75±27.67)and(36.91±32.59)ng·h·mL-1,AUC0-∞ were(36.15±27.89)and(37.14±32.69)ng·h·mL-1.Under both fasting and post-meal conditions,the 90％confidence interval of the geometric mean ratio(GMR)of the main PK parameters of the test formulation of agomelatine tablets compared to the reference formulation fell within the range of 80％-125％.Conclusion The test formulations and reference formulations of agomelatine are bioequivalent under both fasting and fed conditions.关键词
阿戈美拉汀片/药代动力学/生物等效性/安全性Key words
agomelatine tablet/pharmacokinetic/bioequivalence/safety分类
医药卫生引用本文复制引用
肖艳霞,李若茗,杨少杰,杨贵刚,裴莹子,赵晓,谭云龙,陈松..阿戈美拉汀片在中国健康参与者中的生物等效性评价[J].中国临床药理学杂志,2026,42(5):700-705,6.
