Bioequivalence of carvedilol in healthy volunteers

Objective To study the pharmacokinetics of a single dose carvedilol tablets in Chinese healthy volunteers.Methods Twenty healthy volunteers were divided into 2 groups.Twenty mg single oral dose of carvedilol tablets was given to 20 healty volunteers.The concentrations of plasma samples collected from the volunteers respectively were determined by LC-MS.The pharmacokinetic parameters were calaulated by DAS Ver 2.0 software.Results The main pharmacokinetic parameters of carvedilol test and reference tablets were as follow:tmaxwere(0.69±0.24)and(0.76±0.39) h,t1/2were(7.21±5.10)and(7.99±4.70) h,Cmaxwere(63.70±21.45)and(60.02±22.34) μg·L-1,AUC0-twere(161.98±62.24)and(168.15±64.09) μg·h·L-1,AUC0-∞were(173.30±78.42)and(179.49±72.84)μg·h·L-1.The relative bioavailability of drug was(99.3±25.9)%.Conclusion The two carvedilol tablets are bioequivalent.