Study on the Human Body Bioequiavailability of Nevirapine Capsules / 中国药房

ABSTRACT

OBJECTIVE:To study the bioequivalences of both domestic nevirapine capsules and imported nevirapine tablets.METHODS:24healthy male volunteers were administered orally with single dose of either the domestic nevirapine trial capsules or the imported nevirapine reference tablets by randomized crossover way,the blood concentration of nevirapine was determined by HPLC,and the pharmacokinetics parameters and the relative bioavailability of whom were calculated.RE?SULTSThe C max of the trial preparation and the reference preparation were(2.516?0.446)?g/ml and(2.798?0.394)?g/ml,respectively t max were(7.5?10.7)and(3.6?2.1)h,t 1/2 were(51.4?25.3)h and(46.4?9.8)h;AUC 0～168 were(160.540?38.007)(?g?n)/ml and(167.459?30.629)(?g?n)/ml;AUC 0～∞ were(180.064?51.005)(?g?n)/ml and(183.052?36.828)(?g?n)/ml;The relative bioavailability of the trial preparation was(98.368?22.99)%.CONCLUSION:The results shows that the trial preparation and the reference preparation of nevirapine were bioequivalent.