[Translation] A single-center, open-label, randomized, two-formulation, two-sequence, two-cycle, double-crossover human bioequivalence trial of single-dose oral administration of brivaracetam oral solution in Chinese healthy subjects under fasting and postprandial conditions
研究健康受试者空腹及餐后单次口服受试制剂布立西坦口服溶液(海南全星制药有限公司,规格:10mg/mL)与参比制剂布立西坦口服溶液(商品名:Briviact®,规格:10mg/mL)在吸收程度和速度方面是否存在差异,评价受试制剂和参比制剂在空腹及餐后条件下给药时的生物等效性,观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Study healthy subjects' fasting and postprandial oral administration of the test preparation Brivaracetam Oral Solution (Hainan Quanxing Pharmaceutical Co., Ltd., specification: 10 mg/mL) and the reference preparation Briviracetam Oral Solution (trade name: Briviact ®, specification: 10 mg/mL), whether there is any difference in the degree and speed of absorption, evaluate the bioequivalence of the test preparation and the reference preparation when administered under fasting and postprandial conditions, and observe the test preparation and the reference preparation Safety in healthy subjects.