[Translation] A single-center, open-label, randomized, two-dose, two-period, two-sequence, single-dose, double-crossover bioequivalence study of empagliflozin tablets (10 mg) in Chinese healthy subjects in the fasting and fed state
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] The main purpose of the study is to evaluate the bioequivalence of a single oral dose of the test preparation (Empagliflozin Tablets, Shenzhen Osa Pharmaceutical Co., Ltd., 10 mg/tablet) and the reference preparation (Empagliflozin Tablets, Boehringer Ingelheim, Germany, 10 mg/tablet, Otangjing®) in healthy subjects in the fasting and fed state.
The secondary purpose of the study is to observe the safety of the test preparation and the reference preparation when taken orally in the fasting and fed state.