Study of the relative bioequivalence of sustained release capsules of Ibuprofen in healthy volunteers

AIM: To study the relative bioequivalence of sustained release capsules of Ibuprofen made by Jiangxi Pharmaceutical Co.,Ltd.METHODS: A single dose of 300 mg domestic Ibuprofen,and its reference preparation made by Zhengzhou Fusheng Pharmaceuticals Co.,Ltd.were given to 24 healthy volunteers by oral in an open randomized two way crossover experiment.The plasma concentrations were determined by HPLC method.RESULTS:The main pharmacokinetic parameters of a single dose of Ibuprofen were as follows : Cmax were(13.5±5.9) and(12.7±5.4) μg/mL;tmax were(5.1±1.0),(5.5±1.5) h;AUC0-24 were(100.2±45.4) and(98.5±44.8) μg·h·mL-1;AUC0→∞ were(105.7±47.3) and(103.8±47.0) μg·h·mL-1 for the reference drug and the test drug,respectively.The main pharmacokinetic parameters of muti-dose of Ibuprofen were as follows: Cmax were(14.1±5.3) and(14.9±6.4) μg/mL;Cav were(8.2±3.4)and(8.6±4.3) μg/mL;tmax were(4.8±1.0) and(4.6±0.9) h;AUCss were(99.0±40.4) and(103.3±51.3) μg·h·mL-1 for the reference drug and the test drug,respectively.CONCLUSION: Statistic analysis shows that the reference preparation and the test preparation are bioequivalent.