[Translation] A single-center, randomized, open-label, two-formulation, single-dose, fasting, three-period crossover bioequivalence study of brexpiprazole orodispersible film in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,比较在空腹状态下口服受试制剂布瑞哌唑口溶膜(持证商:合肥华方医药科技有限公司)与参比制剂布瑞哌唑片(持证商:Otsuka Pharmaceutical Netherlands B.V.,商品名:Rxulti®)后在健康受试者体内的药代动力学行为,评价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在健康受试者中的安全性;比较空腹条件下受试制剂不同给药方式(给水条件和不给水条件)对相对生物利用度的影响;评价受试制剂布瑞哌唑口溶膜在不给水条件下的适口性(整体口感、异味、甜度、香气、苦味评价)、砂砾感、溶化时间、黏膜粘附性和刺激性。
[Translation] Primary objective: To compare the pharmacokinetic behavior of the test preparation brepirazole orodispersible film (licensed by Hefei Huafang Pharmaceutical Technology Co., Ltd.) and the reference preparation brepirazole tablets (licensed by Otsuka Pharmaceutical Netherlands B.V., trade name: Rxulti®) in healthy subjects after oral administration of the test preparation brepirazole orodispersible film (licensed by Hefei Huafang Pharmaceutical Technology Co., Ltd.) under fasting conditions, and to evaluate the bioequivalence of the two preparations. Secondary objectives: To observe the safety of the test preparation brepirazole orodispersible film and the reference preparation brepirazole tablets in healthy subjects; to compare the effects of different administration methods (water and no water) on the relative bioavailability of the test preparation under fasting conditions; to evaluate the palatability (overall taste, off-flavor, sweetness, aroma, bitterness evaluation), grittiness, dissolution time, mucosal adhesion and irritation of the test preparation brepirazole orodispersible film under no water conditions.