中国临床药理学杂志2024，Vol.40Issue(20)：3033-3037,5.DOI:10.13699/j.cnki.1001-6821.2024.20.025
奥美沙坦酯片在中国健康受试者中的生物等效性研究
Bioequivalence study of olmesartan medoxomil tablet in Chinese healthy subjects
单娜 1杨广德 2刘峰 1江大海 3苗琳琳 3任振丽 3靳鹏博 3郝沛琪 3安莉 3朱红 2辛勇2
作者信息
- 1. 陕西国际商贸学院医药学院,陕西咸阳 712046||山东步长制药股份有限公司,山东菏泽 712000
- 2. 徐州医科大学附属医院Ⅰ期临床试验研究室,江苏徐州 221000
- 3. 山东步长制药股份有限公司,山东菏泽 712000
- 折叠
摘要
Abstract
Objective To study the bioequivalence of test and reference olmesartan tablet in Chinese healthy subjects after single dose under fasting and fed conditions.Methods A single-center,random,open,single-dose,two-preparations,double-period,crossover study was adopted.A total of 48 healthy adult male and female subjects(24 cases of fasting test and 24 cases of fed test)were included in the random crossover administration.Single oral dose 20 mg of test and reference were taken under fasting and postprandial conditions,respectively.Plasma concentration of olmesartan in plasma were determined by liquid chromatography tandem mass spectrometry.The main pharmacokinetic parameters were calculated by Phoenix WinNonlin 8.0 software.Results The main pharmacokinetic parameters of the test and reference preparations of olmesartan tablets in the fasting group were as follows:Cmax were(653.06±133.53)and(617.37±151.16)ng·mL-1,AUC0-t were(4 201.18±1 035.21)and(4 087.38±889.99)ng·mL-1·h,AUC0-∞ were(4 254.30±1 058.90)and(4 135.69±905.29)ng·mL-1·h.The main pharmacokinetic parameters of the test and reference preparations of olmesartan tablets in the postprandial group were as follows:Cmax were(574.78±177.05)and(579.98±107.74)ng·mL-1,AUC0-t were(3 288.37±866.06)and(3 181.51±801.06)ng·mL-1·h,AUC0-∞ were(3 326.11±874.26)and(3 242.01±823.09)ng·mL-1·h.Under fasting and postprandial conditions,the 90％confidence intervals of the main pharmacokinetic parameters of the test and reference preparations are both 80.00％-125.00％.Conclusion Under fasting and postprandial conditions,a single oral dose of test and reference preparations olmesartan tablets in Chinese healthy adult volunteers showed bioequivalence.关键词
奥美沙坦酯片/生物等效性/药代动力学Key words
olmesartan medoxomil tablet/bioequivalence/pharmacokinetic分类
医药卫生引用本文复制引用
单娜,杨广德,刘峰,江大海,苗琳琳,任振丽,靳鹏博,郝沛琪,安莉,朱红,辛勇..奥美沙坦酯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(20):3033-3037,5.
