Study on the bioequivalence of ibuprofen and pseudoephedrine dispersible tablets

OBJECTIVE To study the bioequivalence of ibuprofen and pseudoephedrine dispersible tablets.METHODS In the morning,four tablets of test product(ibuprofen and pseudoephedrine dispersible tablets,each tablet contains ibuprofen 200 mg pseudoephedrine hydrochloride 30 mg) or controlled product(ibuprofen and pseudoephedrine tablets)were given to 22 fasted healthy volunteers in a randomized study.ibuprofen and pseudoephedrine hydrochloride concentrations in plasma were determined by HPLC and naproxen and para-nitroaniline were used as internal standards respectively.The pharmacokinetic parameters of ibuprofen and pseudoephedrine hydrochloride were calculated by 3P97.RESULTS Ibuprofen and pseudoephedrine hydrochloride were fitted to the one compartment opened model with first-order absorption.The main pharmacokinetic parameters were analysed of variance,two sides t-test justified bioequivalence.The statistical results showed that two products were bioequivalent in vivo.CONCLUSION The statistical results shows that the test product is bioequivalent to the controlled product in vivo.