[Translation] An open-label, randomized, single-dose bioequivalence study of a single oral dose of brexpiprazole orodispersible film in healthy adult subjects in the fasting and fed states.
主要试验目的:研究空腹和餐后状态下单次口服受试制剂布瑞哌唑口溶膜(规格:2mg,甘肃普安制药股份有限公司研发)与参比制剂布瑞哌唑片(RXULTI®,规格:2mg,Otsuka Pharmaceutical Netherlands.B.V生产)在健康成年受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要试验目的:评价健康受试者在空腹和餐后状态下,单次口服布瑞哌唑口溶膜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 brepizole orodispersible film (specification: 2 mg, developed by Gansu Puan Pharmaceutical Co., Ltd.) and the reference preparation brepizole tablets (RXULTI®, specification: 2 mg, produced by Otsuka Pharmaceutical Netherlands.B.V) in healthy adult subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fasting and fed state.
Secondary purpose of the study is to evaluate the safety of the test preparation and reference preparation of brepizole orodispersible film in healthy subjects after a single oral administration in the fasting and fed state.