Studies on the bioequivalence of domestic terazosin tablet in healthy volunteers

OBJECTIVE To observe the bioavailability of domestic terazosin tablet and imported tablet.METHODS A single oral dose of 2 mg domestic or imported terazosin tablet was given to 20 healthy volunteers in a randomized crossover study.Terazosin concentrations in plasma were determined by HPLC method.RESULTS The main pharmacokinetics of the two products were as follow: t max (1.08±0.54) and (1.18±0.37) h, c max (44.44±11.72) and (41.28±9.77) μg·L -1 ,MRT (9.48±0.76) and (9.36± 0.90 ) h, t 1/2 (10.10±1.45) and (9.77±1.76) h,AUC 0～36 h (372.82±97.44) and (361.57±83.21) μg·h·L -1 respectively.The relative bioavailability of domestic to imported tablets was (103±13)%.CONCLUSION There was no significant difference between the parameters of two products ( P 0.5).The results demonstrated that the two preparations were bioequivalent.