[Translation] Single-center, open-label, randomized, two-preparation, two-cycle, two-sequence, single-dose, double-crossover bioequivalence of empagliflozin tablets (10 mg) in Chinese healthy subjects under fasting and postprandial conditions test
主要研究目的:评价在健康受试者空腹和餐后状态下单次口服受试制剂(恩格列净片,深圳奥萨制药有限公司,10 mg/片)与参比制剂(恩格列净片,德国勃林格殷格翰公司,10mg/片,欧唐静®)的生物等效性。
次要研究目的:观察空腹和餐后状态下口服受试制剂和参比制剂的安全性。
[Translation] Main research purpose: To evaluate the single oral administration of the test preparation (empagliflozin tablets, Shenzhen Osa Pharmaceutical Co., Ltd., 10 mg/tablet) and the reference preparation (empagliflozin) in healthy subjects under fasting and postprandial conditions. Tablets, Boehringer Ingelheim, Germany, 10 mg/tablet, Bioequivalence of Otangjing®).
Secondary research purpose: To observe the safety of oral administration of the test preparation and reference preparation under fasting and postprandial conditions.