[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of breprazol tablets (2 mg) in Chinese healthy subjects under fasting and fed conditions
主要研究目的:按有关生物等效性试验的规定,选择大塚製薬株式会社为持证商的布瑞哌唑片(商品名:REXULTI®,规格:2mg)为参比制剂,对湖南省湘中制药有限公司提供的受试制剂布瑞哌唑片(规格:2mg)进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评估两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者口服受试制剂布瑞哌唑片(规格:2mg)和参比制剂布瑞哌唑片(商品名:REXULTI®,规格:2mg)的安全性。
[Translation] Main research purpose: According to the regulations on bioequivalence testing, select Bripipiprazole Tablets (trade name: REXULTI®, specification: 2 mg) of Otsuka Manufacturing Co., Ltd. as the licensee as the reference preparation. The test preparation Bripiprazole tablets (specification: 2 mg) provided by Xiangzhong Pharmaceutical Co., Ltd. were subjected to fasting and postprandial administration human bioequivalence tests to compare the absorption speed and extent of the drug in the test preparation with the reference preparation. Whether the difference is within the acceptable range, the bioequivalence of the two formulations under fasting and postprandial administration conditions was evaluated.
Secondary research purpose: To observe the safety of the test preparation Bripipiprazole Tablets (specification: 2 mg) and the reference preparation Bripipiprazole Tablets (trade name: REXULTI®, specification: 2 mg) orally administered to healthy volunteer subjects.