[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of empagliflozin tablets in healthy subjects on an empty stomach
主要研究目的: 研究空腹状态下单次口服受试制剂恩格列净片(规格:10mg,浙江江北药业有限公司生产)与参比制剂恩格列净片(欧唐静®,规格:10mg, Boehringer Ingelheim Pharma GmbH & Co. KG 生产,Boehringer Ingelheim International GmbH持证)在健康成年受试者体内的药代动力学,评价空腹状态口服两种制剂的生物等效性。
次要研究目的: 评价健康受试者在空腹状态下,单次口服恩格列净片受试制剂和参比制剂后的安全性。
[Translation] Main study objectives: To study the pharmacokinetics of the test preparation empagliflozin tablets (specification: 10 mg, produced by Zhejiang Jiangbei Pharmaceutical Co., Ltd.) and the reference preparation empagliflozin tablets (Otangjing®, specification: 10 mg, produced by Boehringer Ingelheim Pharma GmbH & Co. KG, licensed by Boehringer Ingelheim International GmbH) in healthy adult subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations after oral administration under fasting conditions.
Secondary study objectives: To evaluate the safety of the test preparation and reference preparation of empagliflozin tablets after a single oral administration under fasting conditions in healthy subjects.