[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the test formulation of ponatinib tablets (strength: 15 mg) and the reference formulation of Iclusig® (strength: 15 mg) in healthy adult participants in the fasting and fed state
主要研究目的:评估空腹和餐后状态下单次口服受试制剂泊那替尼片(规格:15 mg,持证商:成都硕德药业有限公司)与参比制剂泊那替尼片(Iclusig®,规格:15 mg,持证商:大塚製薬株式会社)在健康参与者体内的药代动力学参数,评价空腹和餐后状态下口服两种制剂的生物等效性。
次要研究目的:评估泊那替尼片(规格:15 mg)与参比制剂泊那替尼片(Iclusig®,规格:15 mg)在健康参与者中的安全性。
[Translation] The main purpose of the study is to evaluate the pharmacokinetic parameters of the test preparation ponatinib tablets (specification: 15 mg, licensee: Chengdu Shuode Pharmaceutical Co., Ltd.) and the reference preparation ponatinib tablets (Iclusig®, specification: 15 mg, licensee: Otsuka Pharmaceutical Co., Ltd.) in healthy participants after a single oral administration in the fasting and fed states, and to evaluate the bioequivalence of the two oral preparations in the fasting and fed states.
Secondary study objective: To evaluate the safety of ponatinib tablets (strength: 15 mg) compared with the reference product ponatinib tablets (Iclusig®, strength: 15 mg) in healthy participants.