Bioequivalence of Brivaracetam Tablets in healthy subjects
Objective To study the bioequivalence of Brivaracetam Tablets under fasting and fed administration.Methods A single-center,single-dose,randomized,open,two-cycle,cross-over trial was conducted.Twenty-eight subjects in the fasting and fed groups were included.Healthy subjects were po administer with Brivaracetam Tablets test or reference preparation of 50 mg(one tablets)with 240 mL warm water in a single dose.HPLC-MS/MS method was used to determine brivaracetam in human plasma samples.Phoenix WinNonlin 8.1 software was used to calculate pharmacokinetic parameters,and SAS 9.4 software was used for statistical analysis.Results The geometric mean values of main pharmacokinetic parameters(AUC0-∞,AUC0-t,and Cmax)of Brivaracetam Tablets two preparations in the two groups were in the range of 80.00%—125.00%.Conclusion The test preparation and reference preparation of Brivaracetam Tablets are bioequivalent in healthy subjects under fasting or fed condition.
NETL
NSTL
万方数据
