[Translation] A single-center, randomized, open-label, single oral administration, two-formulation, three-sequence, three-cycle (fasting)/two-sequence, two-cycle (fed), crossover human bioequivalence study of brexpiprazole orodispersible film in healthy Chinese subjects
主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂布瑞哌唑口溶膜(规格:2mg;生产企业:海南葫芦娃药业集团股份有限公司)和参比制剂布瑞哌唑片(商品名:Rexulti®;规格:2mg;持证商:Otsuka Pharmaceutical Co Ltd)后的药代动力学特征,评价空腹/餐后状态下两种制剂的生物等效性。
次要目的:观察受试制剂布瑞哌唑口溶膜和参比制剂布瑞哌唑片(Rexulti®)在中国健康受试者中的安全性。
[Translation] Primary objective: To observe the pharmacokinetic characteristics of the test preparation brexpiprazole orodispersible film (specification: 2 mg; manufacturer: Hainan Huluwa Pharmaceutical Group Co., Ltd.) and the reference preparation brexpiprazole tablets (trade name: Rexulti®; specification: 2 mg; licensee: Otsuka Pharmaceutical Co Ltd) in Chinese healthy subjects after a single oral administration in the fasting/fed state, and to evaluate the bioequivalence of the two preparations in the fasting/fed state.
Secondary objective: To observe the safety of the test preparation brexpiprazole orodispersible film and the reference preparation brexpiprazole tablets (Rexulti®) in Chinese healthy subjects.