Comparative bioequivalence of domestic and imported nevirapine tablets in human

AIM:To evaluate the bioequivalence of nevirapine between domestic and im ported tablets in human. METHODS:The study was performed with 20 healthy male volunteers according to a randomized 2-way crossover design. The plasma samples were collected at 1,2,3 ,4,6,8,12,24,48,72,120,168 h after taking 200 mg of domestic or importe d nevirapine tablet. The plasma-drug concentrations were determined by HPLC ass ay. RESULTS:The plasma concentration-time curves of domestic and imported nevirapi ne tablets showed as taking a nearly identical course. The main pharmacokinetic parameters o f domestic and imported nevirapine tablets were as follows:(3.95±(s 0.22 ) h) and((4.0±)0.5) h for t_(max),(13.8±(1.9) mg·)L~(-1) and ( (14.0±)2.1) mg·L~(-1) for c_(max),(46±7) h and (42±8) h for t_(1/2) ,(765±198) mg·h·L~(-1) and (779±132) mg·h·L~(-1) for AUC_( 0-168),(839±230) mg·h·L~(-1) and (840±150) mg·h·L~(-1) for AUC_(0-∞),respectively. The relative bioavailability of nevirapine was (97±14) %. CONCLUSION:The method is simple, reproducible and feasible to the pharmacokin etic studies of nevirapine showing bioequivalence of domestic and imported nevir apine tablet.