Bioequivalence of Domperidone Tablets in Healthy Volunteers

OBJECTIVE: To study the bioequivalence of Domperidone tablets in healthy volunteers. METHODS: In randomized cross-over design, 22 healthy volunteers were given single oral dose of test preparations 10 mg and reference preparation 10 mg. The plasma concentration of domperidone was determined by LC-MS/MS. The pharmacokinetic parameters were calculated and the bioequivalence was evaluated using BAPP2.0 software. RESULTS: The main pharmacokinetic parameters of test preparations and reference preparations were as follows:tmax(0.55±0.15)h and (0.57±0.11)h; t1/2(10.22±1.29) h and (10.90±1.44)h;cmax(12.721±5.567)μg·L-1 and (13.265±5.787)μg·L-1;AUC0～36 h(42.550±11.724)mg·h·L-1 and(44.259±8.813)mg·h·L-1;AUC0～∞(45.539±12.327)mg·h·L-1 and (47.900±9.446)mg·h·L-1. The relative bioavailability was (96.5±19.2)%. The main pharmacokinetic parameters showed no statistically significant difference between two preparations. CONCLUSION: Test preparations and reference preparations are bioequivalent.