Bioequivalence of Troxerutin Tablets in Healthy Volunteers

Objective:To evaluate the relative bioavailability and bioequivalence of two kinds of troxerutin tablets in healthy male volunteers.Methods:In a randomized crossover design,20 healthy male volunteers were given a single oral dose of 900 mg test or reference troxerutin tablets.The concentrations of troxerutin in human plasma were determined by a HPLC-MS/MS method.Results:The main pharmacokinetic parameters of the test and reference troxerutin tablets were as follows:c_(max) were(1.83±0.90) and(2.02±1.54) ng/ml,t_(max) were(1.2±0.5) and(1.0±0.4) h,AUC_(0~12h) were(8.48±3.47) and(8.51±5.44) ng·h·ml~(-1),AUC_(0~∞) were(9.47 ± 4.55) and(9.97±6.15) ng·h·ml~(-1),and t_(1/2) were(2.8±2.0) and(4.0±2.4) h,respectively.The relative bioavailability of the test tablets was(113.6±39.5)%.There was no significant difference in c_(max),t_(max),AUC_(0~12h) and AUC_(0~∞) between the two preparations.90% of the confidential interval of c_(max) and AUC were between 70%～143%,and 80%～125% respectively according to those of reference tablets.Conclusion:The two preparations were bioequivalent.