[Translation] A single-center, randomized, open-label, two-formulation, two-sequence, four-period, fully replicated crossover bioequivalence trial of axitinib tablets (5 mg) administered orally in healthy Chinese participants under fasting conditions.
主要研究目的
考察中国健康参与者空腹条件下单次口服阿昔替尼片受试制剂(规格:5mg,生产企业:江西山香药业有限公司)及参比制剂(商品名:英立达®,规格:5mg,持证商:Pfizer Europe MA EEIG)后的药代动力学特征,评价两制剂在空腹条件下是否具有生物等效性。
次要研究目的
评价阿昔替尼片受试制剂(规格:5mg)及参比制剂(商品名:英立达®,规格:5mg)在健康参与者中的安全性。
[Translation] Primary Objective: To investigate the pharmacokinetic characteristics of axitinib tablets (test formulation, 5 mg, manufactured by Jiangxi Shanxiang Pharmaceutical Co., Ltd.) and reference formulation (trade name: Inritar®, 5 mg, licensed by Pfizer Europe MA EEIG) after a single oral administration under fasting conditions in healthy Chinese participants, and to evaluate the bioequivalence of the two formulations under fasting conditions.
Secondary Objective: To evaluate the safety of axitinib tablets (test formulation, 5 mg) and reference formulation (trade name: Inritar®, 5 mg) in healthy participants.