Bioequivalence of domperidone orally disintegrating tablets in healthy volunteers

Objective To study the bioequivalence of domperidone orally disintegrating tablets in comparison with domperidone tablets in healthy volunteers. Methods The randomized and crossover study was conducted in 22 healthy volunteers.After a single dose of the drugs,the plasma concentration of domperidonce was determined by HPLC.Results Both the tested (domperidone orally disintegrating tablets) and reference (domperidone tablets) were fitted to one compartment model.The main pharmacokinetic parameters of the tested and reference domperidone were as follows:C_ max were (40.43±12.89) and (42.31±20.32)μg·mL~ -1 ;t_ max were (0.84±0.29) and (0.91±0.48)h;t_ 1/2(ke) were (11.23±5.06) and (10.13±4.02) h;AUC_ 0-tn were (187.61±81.20) and (189.07±97.69)μg·h·mL~ -1 ;AUC_ 0-∞ were (220.18±106.93) and (215.57±102.13) μg·h·mL~ -1 ;F_ 0-tn and F_ 0-∞ were (102.61±16.41) % and (101.96±16.06)% ,respectively.Conclusion The results of analysis show that the tested and reference are bioeqivalent.