[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of azilsartan tablets in healthy volunteers in the postprandial state (preliminary study)
主要目的:通过健康受试者单次口服由深圳科兴药业有限公司提供的受试制剂阿齐沙坦片与日本武田药品工业株式会社生产的参比制剂阿齐沙坦片,进行人体相对生物利用度研究,评价受试制剂与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评估阿齐沙坦片的安全性。
[Translation] Primary objective: To conduct a human relative bioavailability study on healthy subjects by taking a single oral dose of the test preparation Azilsartan tablets provided by Shenzhen Kexing Pharmaceutical Co., Ltd. and the reference preparation Azilsartan tablets produced by Takeda Pharmaceutical Co., Ltd. of Japan, and to evaluate the bioequivalence of the test preparation and the reference preparation. Secondary objective: To evaluate the safety of Azilsartan tablets by changes in the incidence of adverse events, laboratory test results, vital signs and physical examinations.