[Translation] A postprandial, randomized, open-label, single-dose, two-sequence, two-period, double-crossover study was conducted in healthy adult Chinese subjects to evaluate bioequivalence in the fed state.
主要目的:
按有关生物等效性试验的规定,选择Otsuka Pharmaceutical Netherlands B.V.为持证商的阿立哌唑口崩片(商品名:Abilify,规格:10mg)为参比制剂,对哈尔滨三联药业股份有限公司生产并提供的受试制剂阿立哌唑口崩片(规格:10mg)进行餐后给药条件下的人体生物等效性试验,比较受试制剂与参比制剂的药代动力学特征,评价两种制剂在餐后给药条件下的生物等效性。
次要目的:
观察健康受试者口服受试制剂阿立哌唑口崩片(规格:10mg)和参比制剂阿立哌唑口崩片(商品名:Abilify,规格:10mg)的安全性;
评价阿立哌唑口崩片在中国健康受试者中的适口性,为阿立哌唑口崩片用药口感提供依据。
[Translation] Main purpose: According to the relevant provisions of bioequivalence test, aripiprazole orodisintegrating tablets (trade name: Abilify, specification: 10mg) with Otsuka Pharmaceutical Netherlands B.V. as the licensee were selected as the reference preparation, and the test preparation aripiprazole orodisintegrating tablets (specification: 10mg) produced and provided by Harbin Sanlian Pharmaceutical Co., Ltd. were subjected to human bioequivalence test under the condition of postprandial administration, the pharmacokinetic characteristics of the test preparation and the reference preparation were compared, and the bioequivalence of the two preparations under the condition of postprandial administration was evaluated.
Secondary purpose: Observe the safety of oral administration of the test preparation aripiprazole orodisintegrating tablets (specification: 10mg) and the reference preparation aripiprazole orodisintegrating tablets (trade name: Abilify, specification: 10mg) in healthy subjects;
Evaluate the palatability of aripiprazole orodisintegrating tablets in healthy Chinese subjects, and provide a basis for the taste of aripiprazole orodisintegrating tablets.