中国临床药理学杂志2024，Vol.40Issue(18)：2734-2738,5.DOI:10.13699/j.cnki.1001-6821.2024.18.026
达泊西汀片在中国健康受试者中的药代动力学及食物对其影响的研究
Pharmacokinetics study of dapoxetine tablets in Chinese healthy subjects and the effects of food on its
赵萍 1周芬 1郭军 1王凌 2孙倩1
作者信息
- 1. 聊城市人民医院临床药学科,山东聊城 252000
- 2. 四川大学华西药学院,四川成都 610041
- 折叠
摘要
Abstract
Objective To evaluate the pharmacokinetics and safety of dapoxetine hydrochloride tablets in healthy Chinese subjects,and to assess the impact of food on dapoxetine pharmacokinetics.Methods A single-center,open-lable,two-period,randomized parallel study was conducted.A total of 22 healthy adult male subjects were enrolled and administered a single 30 mg oral dose of dapoxetine hydrochloride tablets,both under fasting and fed condition.Venous blood samples were collected at different time points,and dapoxetine concentrations in human plasma were measured using liquid chromatography tandem mass spectrometry(LC-MS/MS).Pharmacokinetic parameters were calculated using Phoenix WinNonlin 6.3 software,and statistical analysis was conducted with SPSS 19.0 software.Results The main pharmacokinetic parameters after oral administration of dapoxetine hydrochloride tablets in fasting and fed were as follows:Cmax were(230.71±88.91)and(216.27±58.32)ng·mL-1;AUC0-t were(1 054.99±442.11)and(1 292.56±534.49)ng·h·mL-1;AUC0-∞ were(1 175.03±510.58)and(1 447.42±656.25)ng·h·mL-1;tmax were(1.23±0.59)and(2.40±0.90)h;t1/2 were(15.95±6.13)and(16.21±6.34)h.Comparisons between the fasting and fed states,showed statistically significant differences in AUC0-t,AUC0-∞ and tmax(all P＜0.05),but not in Cmax and t1/2(all P＞0.05).The incidence of adverse events was 31.82％in the fasting state and 22.73％in the fed state,with no significant difference(P＞0.05).Conclusion Dapoxetine hydrochloride tablets were rapidly absorbed and eliminated in both fasting and fed states,with good safety;food slowed the absorption rate of dapoxetine and increaseed its overall exposure.关键词
达泊西汀/药代动力学/食物Key words
dapoxetine/pharmacokinetics/food分类
医药卫生引用本文复制引用
赵萍,周芬,郭军,王凌,孙倩..达泊西汀片在中国健康受试者中的药代动力学及食物对其影响的研究[J].中国临床药理学杂志,2024,40(18):2734-2738,5.
