Objective To study the bioequivalence of generic and original dapoxetine hydrochloride tablets 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.Fasting and fed tests were performed on 36 subjects each.Single oral dose 60 mg of test and reference pre parations were taken under fasting and fed conditions,respectively.Plasma concentration of dapoxetine was determined by liquid chromatography tandem mass spectrometry.The main pharmacokinetic(PK)parameters were calculated by Phoenix WinNonlin 8.0 software.Results The main PK parameters of the test and reference preparations of dapoxetine tablets in the fasting group were as follows:Cmax were(449.36±203.01)and(432.85±199.75)ng·mL-1;AUC0-t were(2 400.96±1 392.58)and(2 251.82±1 225.84)ng·mL-1·h;AUC0-∞ were(2 529.94±1 498.05)and(2 371.06±1 305.22)ng·mL-1·h.The main PK parameters of the test and reference preparations of dapoxetine tablets in the fed group were as follows:Cmax were(651.29±179.38)and(672.83±249.42)ng·mL-1;AUC0-t were(3 391.27±1 358.73)and(3 314.56±1 360.39)ng·mL-1·h;AUC0-∞ were(3 630.79±1 605.89)and(3 549.22±1 526.61)ng·mL-1·h.Under the fasting and fed conditions,the 90％confidence intervals of the main PK parameters of the test and reference preparations of dapoxetine tablets are 80.00％-125.00％.Conclusion Under the fasting and fed conditions,a single oral dose of generic and original dapoxetine hydrochloride tablets in Chinese healthy adult volunteers showed bioequivalence.
关键词
盐酸达泊西汀片/生物利用度/生物等效性/健康受试者/液相色谱-串联质谱
Key words
dapoxetine hydrochloride tablet/bioavailability/bioequivalence/healthy subject/liquid chromatography-tandem mass spectrometry
维普
万方数据