Study on the Bioequivalence of Domestic and Imported Fluvoxamin Maleate Tablets in Healthy Volunteers

OBJECTIVE:To study the relative bioavailability of domestic fluvoxamin maleate tablets in healthy volunteers, and to evaluate the bioequivalence of domestic and imported Fluvoxamin maleate tablets. METHODS: A randomized crossover design was performed in 20 healthy male volunteers. A single oral dose of domestic tablets 100 mg (test tablets) or imported tablets 100 mg (reference tablets) were given to volunteers. Plasma concentrations of fluvoxamin maleate were measured by HPLC. The pharmacokinetic parameters were measured by 3p97 software as well as bioequivalence. RESULTS: The plasma concentration-time curves of test tablets and reference tablets conformed to one-compartment model. Main pharmacokinetic parameters of test tablets vs. reference tablets were as follows: t1/2Ke(14.22±9.52) h vs. (12.06±8.94) h; tmax(4.80±2.21) h vs. (4.90±2.45) h;Cmax(31.75±15.84) ng·mL-1 vs. (33.60±19.40) ng·mL-1; AUC0～96(456.12±382.86) ng·h·mL-1 vs. (451.60±379.01) ng·h·mL-1; AUC0～∞(557.69±443.32) ng·h·mL-1 vs. (545.12±429.64) ng·h·mL-1. The relative bioavailability of test tablets was(101.00±14.24)%. There was no significant difference between the two formulations in pharmacokinetic parameters by variance analysis,t test and 1-2α confidence interval method (P0.05). CONCLUSION: Domestic and imported fluvoxamin maleate tablets are bioequivalent.