[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of empagliflozin tablets administered orally once after a meal to participants in a health study.
主要研究目的:研究餐后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)在健康成年研究参与者体内的药代动力学,评价餐后状态口服两种制剂的生物等效性。
次要研究目的:评价健康研究参与者在餐后状态下,单次口服恩格列净片受试制剂和参比制剂后的安全性。
[Translation] Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation empagliflozin tablets (10 mg, manufactured by Zhejiang Jiangbei Pharmaceutical Co., Ltd.) and the reference formulation empagliflozin tablets (Otangjing®, 10 mg, manufactured by Boehringer Ingelheim Pharma GmbH & Co. KG, certified by Boehringer Ingelheim International GmbH) in healthy adult study participants after a meal, and to evaluate the bioequivalence of the two formulations after oral administration after a meal.
Secondary objective: To evaluate the safety of a single oral dose of the test and reference formulations of empagliflozin tablets after a meal in healthy study participants.