Abstract: AIM: To evaluate the pharmacokinetics and bioequivalence of domperidone tablets in healthy volunteers. METHODS: A single dose (20 mg test or reference formation) was given to 18 healthy male volunteers according to an open randomized crossover design. The concentration of domperidone in plasma was determined by LC-MS. The pharmacokinetics parameters were calculated and the bioavailability and bioequivalence of two formulations were evaluated by DAS Ver 2.0. RESULTS: The main pharmacokinetic parameters of domperidone tablets were as follows: C_max were (36±8) and (38±9) μg/L; t_max were (0.6±0.2) and (0.7±0.3) h; t_1/2 were (10±8) and (9±3) h; AUC_0-24 were (138±34) and (144±31) μg·L^-1·h; AUC_0-∞ were (168±68) and (166±37) μg·L^-1·h. As assessed in accordance with AUC_0-24, the relative bioavailability of two formulations was (97±20)%. CONCLUSION: The domperidone formulations are bioequivalent.

Key words: Domperidone, Bioavailability, Bioequiavailability, LC-MS