Bioequivalence study of domperidone tablets in healthy Chinese volunteers

Objective To evaluate the relative bioequivalence of two domperidone preparations in healthy Chinese volunteers by estimated pharmacokinetics based on plasma concentrations of the drugs detected by LC-MS/MS.Methods A single oral dose of two preparations was given to 24 healthy male volunteers according to a randomized crossover design.Plasma drug concentrations were determined by LC-MS/MS.The pharmacokinetic parameters were calculated by BAPP3.0.Results The major pharmacokinetic parameters of domperidone in test and reference preparations were as follows:t1/2(10.2±1.9)and(10.2±2.2)h,Cmax(26±11)and(25±12)μg/L,tmax(0.7±0.5)and (0.6±0.3)h,AUC0～36h(75±24)and(70±27)μg·h-1·L-1,AUC0-∞(80±26)and(74±28)μg·h-1·L-1,respectively.The relative bioavailability of test preparation was (114±30)%.Conclusion The two preparations were bioequivalent in human body.