Bioequivalent study of secnidazole in healthy volunteers

Objective To study the bioequivalence of secnidazole capsule in healthy volunteers. Methods Twenty-one normal male volunteers were enrolled in a randomized crossover study. Each volunteer was given a single oral dose of secnidazole capsule (test preparation) and reference preparation (tablet) for comparison. The serum concentrations of secnidazole were determined by HPLC. Results The pharmacokinetic parameters of secnidazole capsule and reference tablet after oral dose of 1 000 mg of secnidazole were C_ max (22.69±3.60) and (23.29±3.62) mg/L respectively, T_ max (1.18±0.49) and (1.15±0.65) h respectively, t_ 1/2β (26.43±5.77) and (27.08±5.46) h respectively, AUC_ 0-t (701.12±123.89) and (709.93±89.06) h·mg/L respectively, AUC_ 0-∞ (761.14±147.96) and (773.71±108.23) h·mg/L respectively. The bioavailability of secnidazole were (98.73±11.34) % based on AUC_ 0-t ,and (98.38±12.83)% based on AUC_ 0-∞ . Conclusions The serum concentration-time data of secnidazole fit into a two-compartmental model. Results show that test preparation and reference tablet are bioequivalent.