Study on the Relative Bioavailability of Propylthiouracil Enteric Coated Capsules / 中国药房

ABSTRACT

OBJECTIVE:To evaluate the bioavailability of domestic propylthiouracil enteric coated capsule.METHODS:A modified RP-HPLC assay was used for determination of the plasma drug concentrations.In a randomized two-way crossover design,a single oral dose of100mg domestic propylthiouracil capsule(trial agent,A)and imported propyithiouracil tablet(reference agent,B)were given to20male healthy volunteers.The parameters were fitted by CRFB bioavailaility soft?ware.RESULTS:The AUC 0～t ,C max and t max of A and B were(9.13?1.53)and(8.80?1.37)(?g?h)/ml,(3.02?0.71)and(3.03?0.66)?g/ml,(4.51?0.24)and(1.13?0.44)h respectively.There were no significant differences in parameters between2groups.The relative bioavailability of product A was(104.37?12.16)%.CONCLUSION:The results suggest that these two products were bioequivalent.