[Translation] A single-center, randomized, open-label, 3×3 Latin square design, pharmacokinetics comparison of briracetam extended-release tablets and briracetam tablets in Chinese healthy subjects
主要目的:以泰州越洋医药开发有限公司研制的布立西坦缓释片(规格:100mg)为受试制剂A(T1),布立西坦缓释片(规格:50mg)为受试制剂B(T2),以UCB生产的布立西坦片(商品名:BRIVIACT®,规格:50mg)为参比制剂(R),比较受试制剂A(T1)与受试制剂B(T2)、受试制剂A(T1)与参比制剂、受试制剂B(T2)与参比制剂之间的体内的血药浓度及主要药代动力学参数,评价受试制剂的相对生物利用度及缓释特性。 次要目的:评价中国健康受试者空腹状态下口服受试制剂A(T1)、B(T2)布立西坦缓释片和参比制剂(R)布立西坦片后的安全性。
[Translation] Main purpose: Take briracetam sustained-release tablets (specification: 100mg) developed by Taizhou Yueyang Pharmaceutical Development Co., Ltd. as the test preparation A (T1), and briracetam sustained-release tablets (specification: 50mg) as the test preparation B (T2), using briracetam tablets (trade name: BRIVIACT®, specification: 50 mg) produced by UCB as the reference preparation (R), compare the test preparation A (T1) with the test preparation B (T2), The in vivo blood concentration and main pharmacokinetic parameters between the test preparation A (T1) and the reference preparation, the test preparation B (T2) and the reference preparation, evaluate the relative bioavailability and delay of the test preparation. release characteristics. Secondary objective: To evaluate the safety of test preparations A (T1), B (T2) briracetam sustained-release tablets and reference preparation (R) briracetam tablets after oral administration in healthy Chinese subjects under fasting conditions.