Study on Bioequivalence of Polyferose Capsules

OBJECTIVE:To study the bioequivalence of polyferose capsule and imported Niferex in healthy volunˉteers.METHODS:In a randomized two-way crossover design,a single oral dose of150mg polyferose capsule(A)and Niferex(B)were given to20male healthy volunteers.The serum iron concentrations within12h after administration were determined with atomic absorption spectrometry and parameters C max ,T max ,AUC 0～t and AUC 0～∞ were obtained and analysed with two-one sided t test.RESULTS:The AUC 0～t ,C max ,T max ,T 1/2 and AUC 0～∞ of A and B were6.58μg/(h·ml)and6.58μg/(h·ml),1.07μg/ml and1.10μg/ml,3.93h and3.93h,2.33h and2.33h,6.95μg/(h·ml)and6.93μg/(h·ml)respectively.There were no significant difference between A and B(P0.05)and the differences of AUC 0～t ,T max and C max were not significant as verified by two-one sided t test.CONCLUSION:The relative bioequivalence of polyferose capsules is101.02%which indicates that polyferose capsule is a bioequivalent product of Niferex capsule.