Kangyuan Huawei Pharmaceutical Co., Ltd.

The test preparation was ezetimibe atorvastatin calcium tablets (specification: 10 mg/10 mg) owned by Kangyuan Huawei Pharmaceutical Co., Ltd., and the reference preparation was ezetimibe atorvastatin calcium tablets (ATOZET®, specification: 10 mg/10 mg) marketed by Merck Sharp & Dohme. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Main purpose: Using empagliflozin tablets (25 mg) developed by Kangyuan Huawei Pharmaceutical Co., Ltd. as the test preparation and empagliflozin tablets (Jardiance®, 25 mg) marketed by Boehringer Ingelheim International GmbH as the reference preparation, the pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations are bioequivalent. Secondary purpose: To evaluate the safety of the test and reference preparations of empagliflozin tablets after single oral administration in Chinese healthy subjects in the fasting and postprandial states.

The pharmacokinetic parameters were used as the primary endpoint evaluation indicators to compare the pharmacokinetic behavior of the test preparation Telmisartan Amlodipine Tablets (certificate holder: Kangyuan Huawei Pharmaceutical Co., Ltd., manufacturer: Jiangsu Kangyuan Pharmaceutical Co., Ltd.) and the reference preparation Telmisartan Amlodipine Tablets (certificate holder: Boehringer Ingelheim International GmbH, trade name: Twynsta®) in healthy subjects after oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations.