[Translation] A single-center, randomized, open-label, single-dose, two-formulation, three-sequence, three-period (fasting) / two-sequence, two-period (postprandial), crossover human bioequivalence trial of birepiprazole oral disintegrating 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 investigational formulation, birepiperazole orally disintegrating film (2 mg; manufactured by Hainan Huluwa Pharmaceutical Group Co., Ltd.), and the reference formulation, birepiperazole tablets (trade name: Rexulti®; 2 mg; licensee: Otsuka Pharmaceutical Co Ltd), after a single oral administration in healthy Chinese subjects under fasting/postprandial conditions, and to evaluate the bioequivalence of the two formulations under fasting/postprandial conditions.
Secondary objective: To observe the safety of the investigational formulation, birepiperazole orally disintegrating film, and the reference formulation, birepiperazole tablets (Rexulti®), in healthy Chinese subjects.