[Translation] A randomized, open-label, single-dose, two-sequence, two-formulation, two-period, double-crossover bioequivalence study of a single oral dose of brexpiprazole tablets in healthy subjects in the fasting state
主要研究目的:研究空腹状态下单次口服受试制剂布瑞哌唑片(规格:2mg,杭州和泽坤元药业有限公司研发)与参比制剂布瑞哌唑片(REXULTI®,规格:2mg,Otsuka Pharmaceutical Co., Ltd持证)在健康受试者体内的药代动力学,评价空腹状态口服两种制剂的生物等效性。
次要研究目的:评价健康受试者在空腹状态下,单次口服布瑞哌唑片受试制剂和参比制剂后的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation brepirazole tablets (specification: 2 mg, developed by Hangzhou Heze Kunyuan Pharmaceutical Co., Ltd.) and the reference preparation brepirazole tablets (REXULTI®, specification: 2 mg, certified by Otsuka Pharmaceutical Co., Ltd) in healthy subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations after oral administration under fasting conditions.
Secondary purpose of the study is to evaluate the safety of the test preparation and reference preparation of brepirazole tablets after a single oral administration under fasting conditions in healthy subjects.