Pharmacokinetics and Relative Bioavailability Study of Nevirapine in Healthy Volunteers

OBJECTIVE To evaluate relative bioavailability of domestic nevirapine in healthy volunteers.METHODS A single oral dose of 200 mg nevirapine domestic and imported tablets,was given to 20 health volunteers in a randomized cross-over study.The nevirapine concentrations in plasma were determined by HPLC method.RESULTS The concentrations of two formulations were fitted to an one-com- partment open model.The main pharmacokinetic parameters of two nevirapine tablets were as follows:t_(max)(3.50±1.05)and(4.20±1.24) h;ρ_(max) were(2 394±392)and(2170±434)μg·L~(-1);t_(1/2ka)(0.85±1.00)and(0.79±0.51)h;t_(1/2ke)(52.30±13.82)and(55.59±10.51)h;AUC_(0～t)(149.20±30.54)and(154.05±27.77)mg·h·L~(-1);AUC_(0～∞)(168.30±40.22)and(173.30±36.65)mg·h·L~(-1), respectiely.The relative bioavalability of F_(0～t) and F_(0～∞)(104.97±16.51)% and(105.21±18.93)%,respectively.CONCLUSION The ANOVA and two one-sided t test statistical analysis show that two formulations are bioequivalent.