[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study of empagliflozin tablets in healthy adult subjects in the fasting and fed state
主要研究目的:评估受试制剂恩格列净片 10 mg 与参比制剂恩格列净片(JARDIANCE
®)10 mg 在健康成年受试者体内的药代动力学,评价空腹/餐后状态下口服两种制剂的生物等效性。
次要研究目的:观察受试制剂恩格列净片和参比制剂恩格列净片(JARDIANCE®)在健康人群中的安全性。
[Translation] The main purpose of the study is to evaluate the pharmacokinetics of the test preparation, 10 mg empagliflozin tablets, and the reference preparation, 10 mg empagliflozin tablets (JARDIANCE
®) in healthy adult subjects, and to evaluate the bioequivalence of the two preparations when taken orally in the fasting/fed state.
The secondary purpose of the study is to observe the safety of the test preparation, empagliflozin tablets, and the reference preparation, empagliflozin tablets (JARDIANCE®) in healthy people.