Pharmacokinetics and Bioequivalence of Secnidazole in Human Body

OBJECTIVE:To evaluate the bioequivalence of domestic secnidazole tablet,capsule and imported secnidazole tablet in healthy volunteers.METHODS:18healthy volunteers were randomly divided into3groups according to a triple-cross design,all the volunteers were given a single dose of1g secnidazole,the interval for washout period of3times adminisˉtration was14days.The plasma drug concentration of secnidazole was determined by HPLC-UV.RESULTS:The main pharmacokinetic parameters of homemade tablet and homemade capsule and imported tablet were as follow,t max were(2.00±1.93),(2.67±2.14)and(1.54±1.53)h respectively,t 1/2 were(28.56±4.98)、(29.69±6.81)and(27.16±5.06)h,C max were(25.50±2.74),(24.27±3.76)and(25.64±4.10)μg/ml respectively.AUC 0～t were(736.03±73.20),(704.78±88.51)and(737.77±76.02)(μg·h)/ml respcetively.AUC 0～∞ were(886.36±114.50),(864.57±172.27)and(870.64±100.21)(μg·h)/ml respectively.The relative bioavailability of homemade tablet was(100.02±6.73)%,and that of homemade capsule was(95.91±10.66)%.CONCLUSION:3preparations of secnidazole are bioequivalent.