目的 研究布瓦西坦片在空腹和餐后給藥狀態(tài)下的生物等效性。方法 采用單中心、單劑量、隨機(jī)、開放、兩周期、交叉試驗(yàn)設(shè)計(jì)，空腹和餐后組28例受試者最終入組，分別單次給予布瓦西坦片受試制劑或參比制劑50 mg即1片，用240 mL溫水送服。采用HPLC-MS/MS法測(cè)定人血漿樣本中布瓦西坦，使用Phoenix WinNonlin 8.1軟件計(jì)算藥動(dòng)學(xué)參數(shù)，SAS 9.4軟件進(jìn)行統(tǒng)計(jì)分析。結(jié)果 布瓦西坦片兩種制劑的主要藥動(dòng)學(xué)參數(shù)（AUC_0-∞、AUC_0-t和C_max）幾何均值均在生物等效性80.00%～125.00%。結(jié)論 布瓦西坦受試制劑與參比制劑在健康受試者空腹和餐后給藥狀態(tài)下具有生物等效性。

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 (AUC_0-∞, AUC_0-t, and C_max) 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.

R927.1；R969.1