[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study of breprazol orodisintegrating tablets in healthy adult subjects under fasting and fed conditions
主要研究目的:研究空腹/餐后状态下单次口服受试制剂布瑞哌唑口崩片(规格2 mg)与参比制剂布瑞哌唑口崩片(Rexulti® OD Tablets,规格:2 mg;大塚製薬株式会社(OtsukaPharmaceutical Co.,Ltd.)持证)在健康成年受试者体内的药代动力学,评价空腹/餐后状态下口服两种制剂的生物等效性。
次要研究目的:观察受试制剂布瑞哌唑口崩片和参比制剂Rexulti® OD Tablets在健康成年受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation brexpiprazole orodisintegrating tablets (specification: 2 mg) and the reference preparation brexpiprazole orodisintegrating tablets (Rexulti® OD Tablets, specification: 2 mg; certified by Otsuka Pharmaceutical Co., Ltd.) in healthy adult subjects after a single oral administration in the fasting/fed state, and to evaluate the bioequivalence of the two preparations when taken orally in the fasting/fed state.
Secondary study objective: To observe the safety of the test preparation brexpiprazole orally disintegrating tablets and the reference preparation Rexulti® OD Tablets in healthy adult subjects.