[Translation] A single-center, single-dose, randomized, open-label, two-agent, two-cycle, double-crossover bioequivalence clinical trial of Azilsartan Tablets in Chinese healthy subjects
比较在空腹和餐后条件下,中国健康受试者单剂量口服瑞阳制药有限公司生产的阿齐沙坦片(受试制剂,20mg/片)与日本武田药品工业株式会社生产的阿齐沙坦片(参比制剂,20mg/片)后血浆中阿齐沙坦的浓度,以药动学参数为终点评价指标,评价受试制剂与参比制剂的生物等效性,同时评估受试制剂与参比制剂的安全性
[Translation] Comparing the single-dose oral administration of Azilsartan tablets (test preparation, 20 mg/tablet) produced by Ruiyang Pharmaceutical Co., Ltd. in healthy subjects in China with Azilsartan produced by Takeda Pharmaceutical Co., Ltd. of Japan under fasting and postprandial conditions The concentration of azilsartan in plasma after Tan tablet (reference preparation, 20mg/tablet), with pharmacokinetic parameters as the endpoint evaluation index, to evaluate the bioequivalence of the test preparation and the reference preparation, and to evaluate the test preparation at the same time Safety with reference product