Empagliflozin/Sitagliptin/Metformin Hydrochloride

Primary objective: Empagliflozin Sitagliptin Metformin Extended-Release Tablets (10 mg/50 mg/500 mg/tablet) developed by Yueyang Pharmaceutical Development (Guangzhou) Co., Ltd. were used as the test formulations. Metformin hydrochloride extended-release tablets (500 mg/tablet, Glucophage XR®/Glucophage®, licensee and manufacturer: Merck Pharmaceuticals (Jiangsu) Co., Ltd.), sitagliptin phosphate tablets (50 mg/tablet, Shengyiping®, Chongqing Shenghuaxi Pharmaceutical Co., Ltd.), empagliflozin tablets (10 mg/tablet, Jardiance®/Ou Tangjing®, Boehringer Ingelheim Pharma GmbH & Co. The study used a single, one-tablet oral dose of the test formulation (KG) as a comparator. The plasma concentrations and key pharmacokinetic parameters of the test formulation (single dose, one tablet each) were compared with those of the comparator formulation (three single-dose combinations, one tablet each) in healthy Chinese volunteers under fasting conditions. The equivalence of the test formulation under the AUC and the PK profiles (including peak plasma concentration (Cmax), time to peak (Tmax), and half-life (t½)) were evaluated between the two formulations. Secondary objective: To evaluate the safety and tolerability of the test formulation, empagliflozin/sitagliptin/metformin extended-release tablets, and the comparator formulation, metformin extended-release tablets, sitagliptin phosphate tablets, and empagliflozin tablets, after oral administration under fasting conditions in healthy Chinese volunteers.