Objective:To study the pharmacokinetic characteristics of oral calcium dobesilate capsules in healthy Chinese subjects,and to evaluate the bioequivalence and safety of the test and reference preparations in both fasting and postprandial states.Methods:Fasting and postprandial groups included 24 subjects in each group for two cycles of randomized open trial.Subjects were orally administered the test or reference preparations in fasting or postprandial state,respectively,and cross-administered during cycleⅡ.The concentrations of calcium dobesilate in human plasma were detected by UHPLC-MS/MS.Phoenix WinNonlin 8.0 was used to calculate the pharmacokinetic parameters and the bioequivalence of the two preparations were evaluated.Results:The 90%confidence intervals of Cmax,AUC0～t and AUC0～∞ of the two preparations were 83.35%～95.97%,93.78%～100.19%,94.44%～98.95%in fasting state,and 86.81%～99.48%,94.07%～98.94%,96.12%～100.37%in postprandial state,respectively.All the data fell within the equivalent range of 80.00%～125.00%.The incidence of adverse events in fasting and postprandial trials was 20.8%and 33.3%,respectively,and no serious adverse events were found.Conclusion:The test and reference preparations of calcium dobesilate capsules were bioequivalent and the safety was found to be acceptable.
维普
万方数据