Pharmacokinetics and Bioequivalence of Domperidone Chewable Tablets in Healthy Volunteers

OBJECTIVE To study pharmacokinetics and bioequivalence of domperidone chewable tablets in healthy Chinese volunteers.METHODS A single oral dose of 10 mg tested domperidone chewable tablets or reference domperidone tablets was given to 18 healthy volunteers in a randomized crossover study.The plasma sample was deproteined by precipitation with methanol and determined by LC-MS/MS method.The pharmacokinetic and relative bioavailability were studied.RESULTS The pharmacokinetic parameters of test and reference formulations were as follows:tmax(0.59±0.29) and(0.67±0.43) h,ρmax(11.27±4.31) and(10.87±4.31) μg.L-1,t1/2(6.97±1.96) and(6.97±2.34) h,AUC0-t(37.89±13.15) and(37.54±12.53) μg.h.L-1,AUC0～∞(41.53±13.96) and(41.67±13.56) μg.h.L-1.The relative bioavailability of test to reference tablets was(102.35±21.85)%.ρmax,AUC0~t and AUC0～∞ were tested by two one-side test and analyzed for bioequivalence after log transformation of data.tmax was analyzed by Wilcoxon’s test.No significant difference was found between two preparations(P0.05).CONCLUSION The results demonstrated that the two preparations were found to be bioequivalent and thus,can be prescribed interchangeably.