Pharmacokinetics and Bioequivalence of Isosorbide Mononitrate and Aspirin Sustained-Release Tablets in Human

According to a randomized crossover design,the pharmacokinetics and bioequivalence after single or multiple dose oral administration of isosorbide mononitrate/aspirin sustained-release tablets (test preparations), isosorbide mononitrate sustained-release tablets and aspirin enteric-coated tablets (reference preparations) in 20 healthy male volunteers were investigated.The concentrations of isosorbide mononitrate and salicylic acid in plasma were determined by HPLC-MS and HPLC-UV,respectively.The main pharmacokinetic parameters were showed in Tab1 and Tab2.The test preparation showed bioequivalence for the isosorbide mononitrate component with isosorbide mononitrate sustained-release tablets,and equivalent AUC for the aspirin component with aspirin enteric-coated tablets,but the test preparation was more rapidly absorbed for the aspirin component than the reference preparation.