Pharmacokinetics and bioequivalence of navirapine tablets in healthy volunteers

Objective To study the pharmacokinetics and bioequivalence of two demostic nevirapine tablets in haealthy volunteers.Methods Twenty healthy volunteers were randomized into two groups,whose plasma concentrations of nevirapine were determined at different time after single oral dose of 200 mg nevirapine tablets by own control by HPLC method,the pharmacokinetic parameters were computed and which were experienced variance analysis.Results The main pharmacokinetic parameters of reference and test navirapine tablets were as follows: tmax were(3.5 ± 2.1),(3.0 ± 1.9) h;Cmax were(2.6 ± 0.5),(2.6 ±0.5) mg·L-1;t1/2 were(57.6 ± 10.4),(58.6 ± 10.2) h;MRT were(55.6 ± 6.5),(56.8 ±5.0)h;AUC0-t were(167.6 ± 36.1),(171.8 ± 32.7) mg·L-1·h;AUC0→∞(169.9 ± 36.6),(174.2 ± 33.1)mg·L-1·h;CL/F(1.2 ± 0.3),(1.2 ± 0.2)L·h-1;Vd/F were(100.3 ± 20.4),(99.4 ± 20.8) L,respectively.The relative bioavailability of the test preparation was(103.7 ± 11.6) %.Conclusion The results shows that the test and reference preparations of nevirapine were bioequivalent.