中国临床药理学杂志2024，Vol.40Issue(16)：2373-2377,5.DOI:10.13699/j.cnki.1001-6821.2024.16.015
盐酸伐地那非片在中国健康受试者中的生物等效性研究
Bioequivalence study of vardenafil hydrochloride tablets in Chinese healthy subjects
摘要
Abstract
Objective To evaluate the bioequivalence of the vardenafil hydrochloride tablets in fasting and fed conditions in healthy Chinese adult subjects with the test and reference formulations.Methods A randomized,open,single-dose,two-preparation,two-sequence,two-period,crossover design was used,and 40 healthy male subjects enrolled in the fasting state and 66 healthy male subjects enrolled in the fed state.The trial was conducted in two cycles,with 20 mg of either the subject formulation or the reference formulation,vardenafil hydrochloride tablets,being administered in each cycle.The drug concentration of vardenafil in plasma was determined by the liquid chromatography-tandem mass spectrometry(LC/MS-MS)method.Pharmacokinetic parameters were calculated using the non-compartment model,and the safety evaluation indexes were statistically analyzed using SAS 9.4 or above version program data statistical software.Results Arithmetic mean values of the main pharmacokinetic parameters of the subject formulation of vardenafil hydrochloride tablets and the reference formulation in the fasting state:Cmaxwere(34.94±18.33)and(36.69±19.45)ng·mL-1;AUC0-t were(74.38±34.11)and(74.25±33.37)ng·mL-1·h;AUC0-∞ were(76.70±34.36)and(76.46±33.84)ng·mL-1·h,respectively.Arithmetic mean values of the main pharmacokinetic parameters of the subject formulation of vardenafil hydrochloride tablets and the reference formulation in the fed state:Cmax were(22.84±12.48)and(21.68±11.12)ng·mL-1;AUC0_twere(70.82±35.88)and(72.71±34.63)ng·mL-1·h;AUC0-∞ were(73.48±36.44)and(75.29±35.12)ng·mL-1·h,respectively.The 90％confidence intervals for the geometric mean ratios of the main pharmacokinetic parameters such as Cmax,AUC0-t and AUC0-∞ of the prototype drug vardenafil in plasma after oral administration of 20 mg of the test and reference formulations of vardenafil tablets to the subjects in fasting and postprandial states fell within the equivalence interval of 80.00％to 125.00％.Conclusion The subject formulation of vardenafil hydrochloride tablets was bioequivalent to the reference formulation in fasting and fed conditions in healthy Chinese subjects.关键词
盐酸伐地那非片/药代动力学/生物等效性/液相色谱串联质谱法Key words
vardenafil hydrochloride tablet/pharmacokinetics/bioequivalence/liquid chromatography-tandem mass spectrometry分类
医药卫生引用本文复制引用
徐媛媛,王小妮,谢晶,张峰,张文,赵胜龙,周焕,黄顺旺..盐酸伐地那非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(16):2373-2377,5.基金项目
创新药物药学研究与临床评价安徽省联合共建学科重点实验室 （）
