Pharmacokinetic properties and bioequivalence of secnidazole tablets in healthy volunteers

OBJECTIVE To evaluate the pharmacokinetic profiles and bioequivalence of secnidazole tablets in healthy volunteers.METHODS A single oral dose of(2.0 g) secnidazole test and reference tablets were given to 20 male healthy volunteers in a randomized crossover design.Secnidazole concentrations in plasma were determined by RP-HPLC.The pharmacokinetic parameters and relative bioavailability were calculated with DAS program to evaluate the bioequivalence of the two preparations.RESULTS The main pharmacokinetic parameters of secnidazole test and reference tablets were as follow:t_(1/ 2)were((27.1)±(4.2)) h and((26.6) ±(4.7)) h;t_(max) were((2.3)±(1.1))h and((2.9)±(1.1))h;C_(max) were((49.6)±(6.4))mg·L~(-1)and ((46.2)±(4.2))mg·L~(-1);AUC_(0-96)were((1832.0)±(180.2))mg·L~(-1)·h and((1847.1)±(204.1))mg·L~(-1)·h;AUC_(0-∞) were((2 022.4)±(205.7))mg·L~(-1)·h and((2 042.27)±(264.03))mg·L~(-1)·h,respectively.The differences of the major pharmacokinetic parameters between test and reference tablets were not significant.The relative bioavailability of test tablet was((99.99)±(11.92))%.CONCLUSION The statistical analysis of the results shows that the two preparations are bioequivalent.