Pharmacokinetics and bioequivalence of terazosin orally disintegrating tablets

Objective To study the pharmacokinetics and bioequivalence between two kinds of terazosin tablets in healthy volunteers.Methods A single oral dose of two kinds of terazosin tablets was given to 18 healthy volunteers in a randomized two-period crossover study.The concentrations of terazosin in plasma were determined by the liquid chromatography tandem mass spectrometry(LC-MS-MS).The plasma concentration-time curves were plotted and the main pharmacokinetic parameters were calculated.Results The main pharmacokinetic parameters of test and reference tablets in plasma were shown as follows:tmax were(1.3±0.8) and(1.2±0.8)h,ρmax were(62.9±20.4) and(62.0±15.3)μg·L-1,t1/2 were(10.2±1.3) and(10.7±1.3)h,AUC0-t were(556.3±162.6) and(584.2±124.2)μg·h·L-1,AUC0-∞were(576.4±169.9) and(611.7±126.5)μg·h·L-1,respectively.The relative bioavailability of the tested drug was(96.2±22.4)%.Conclusions The two kinds of terazosin formulations are bioequivalent in healthy volunteers.