Study of the bioequivalence of domperidone orally disintegrating tablets in Chinese healthy volunteers

OBJECTIVE To study the relative bioavailability and bioequivalence of domperidone orally disintegrating tablets in healthy volunteers.METHODS A single oral dose(20 mg of test and reference formulation) were given to 18 healthy volunteers in a randomised crossover study.The concentrations of domperidone in plasma were determined by HPLC.The pharmacokinetics parameters were calculated and the bioavailability and bioequivalence of two formulations were evaluated by DAS program.RESULTS After a single dose,the pharmacokinetics parameters for domperidone were as follows:Cmax were(31.0±5.5)μg·L-1 and(33.7±10.8)μg·L-1;Tmax were(0.56±0.14) h and(0.63±0.13) h;AUC(0-36) were(204.2±85.0)μg·h·L-1 and(186.8±58.6)μg·h·L-1;AUC(0-inf) were(244.8±114.1)μg·h·L-1and(215.4±56.5)μg·h·L-1 for T and R respectively.The 90% confidential interval of Cmax、AUC(0-36) and AUC(0-inf) of the test formulation were 86.3-104.8%,96.2-116.5% and 94.4-120.8% respectively.CONCLUSION The relative bioavailability is(108.5±25.1)%;The results of the statistic analysis show that the two formulations are bioequivalent.