[Translation] A randomized, open-label, two-dose, two-period, crossover, fasting and fed bioequivalence study of dacomitinib tablets in healthy volunteers
主要目的:
研究健康受试者在空腹/餐后状态下,单次口服由北京康立生医药技术开发有限公司的达可替尼片15mg(受试制剂)和辉瑞制药(Pfizer Limited/Europe MA EEIG)为持证商的达可替尼片15mg(Dacomitinib Tablets/ Vizimpro®/多泽润®),参比制剂)的相对生物利用度,评价受试制剂和参比制剂的生物等效性。
次要目的:
通过不良事件发生率、实验室检验结果、生命体征和体格检查等的变化情况观察受试制剂和参比制剂在中国健康受试者中的安全性和耐受性。
[Translation] Primary objective:
To study the relative bioavailability of 15 mg Dacomitinib Tablets (Dacomitinib Tablets/ Vizimpro®/ DuoZhenrun®) (reference preparation) of Beijing Kanglisheng Pharmaceutical Technology Development Co., Ltd. and Pfizer Limited/Europe MA EEIG (Dacomitinib Tablets/ Vizimpro®/ DuoZhenrun®) (reference preparation) in healthy subjects in the fasting/postprandial state after a single oral administration, and to evaluate the bioequivalence of the test preparation and the reference preparation.
Secondary objective:
To observe the safety and tolerability of the test preparation and the reference preparation in healthy Chinese subjects through changes in adverse event incidence, laboratory test results, vital signs and physical examinations.