Pharmacokinetics and Bioequivalence of Domestic Nisoldipine Tablets in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To study the relative bioavailability,pharmacokinetics and bioequivalence of domestic nisoldipine tablets in healthy volunteers.METHODS:A single oral dose of 10 mg test and reference nisoldipine tablets were given to 24 male healthy volunteers in an open randomized 2?2 latin square design.The plasma concentrations of nisoldipine at different time points were determined by LC-MS and the pharmacokinetic parameters of the two kinds of tablets were computed and their bioequiavailability was evaluated.RESULTS:The main pharmacokinetic parameters of the test vs.reference formulations of nisoldipine in 24 healthy volunteers were as followsCmax(2.94?2.78)ng?mL-1 vs.(3.22?2.16)ng?mL-1,tmax(1.70?1.00)h vs.(1.40?1.00)h,t1/2(6.81?4.11)h vs.(5.55?2.35)h,AUC0～24(10.60?7.70)ng?h?mL-1 vs.(9.90?6.76)ng?h?mL-1,AUC0～∞(11.30?7.90)ng?h?mL-1 vs.(10.20?7.00)ng?h?mL-1.The relative bioavailability of domestic nisoldipine tablets was(110.3?30.8)%.CONCLUSION:The reference preparation and the test preparation of nisoldipine tablets were proved to be bioequivalent.