Study on bioequivalence of imported and domestic terazosin hydrochloride tablets in volunteers

Objective:To evaluate the pharmacokinetics and bioequivalence of imported and domestic terazosin hydrochloride tablets.Methods: Twenty-four healthy male volunteers were randomly administered a single crossover dose of 2 mg test and reference tablets.The concentrations of terazosin in plasma were determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS) method after protein precipitation.The pharmacokinetic parameters of terazosin hydrochloride test and reference tablets were statistically calculated and the bioequivalence was evaluated.Results: The main pharmacokinetic parameters of test and reference tablets were as follows: t1/2(9.55±1.19) and(9.95±1.45) h,tmax(1.20±0.88) and(1.28±1.28) h,cmax(57.59±16.61) and(57.12±17.83) ng/mL,AUC0-48(621.96±152.54) and(607.52±126.03) ng·h·mL-1,AUC 0-∞(640.81±156.06) and(628.52±127.69) ng·h·mL-1,respectively.The relative bioavailability of test formulation was(102.10±9.91)%.Conclusion: The test tablets are bioequivalent to the reference tablets.