2010•Zhongguo linchuang yaolixue yu zhiliaoxueRequires access
Bioequivalence of domperidone tablets in healthy male volunteers
Li Ling, Na Gao, Juan Gu, Yan Jin, Yang Guoping, Dongsheng Ouyang
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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: Cmax were(36±8) and(38±9) μg/L;tmax were(0.6±0.2) and(0.7±0.3) h;t1/2 were(10±8) and(9±3) h;AUC0-24 were(138±34) and(144±31) μg·L-1·h;AUC0-∞ were(168±68) and(166±37) μg·L-1·h.As assessed in accordance with AUC0-24,the relative bioavailability of two formulations was(97±20)%.CONCLUSION: The domperidone formulations are bioequivalent.