Qingdao Huanghai Pharmaceutical Operation Co. Ltd.

Primary objective: This study aims to study the pharmacokinetic characteristics of empagliflozin tablets (25 mg) developed and produced by Qingdao Huanghai Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal; using empagliflozin tablets (Jardiance®, 25 mg) from Boehringer Ingelheim International GmbH as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations was evaluated. Secondary objective: To observe the safety of the test preparation empagliflozin tablets and the reference preparation (Jardiance®) in healthy subjects.

Healthy subjects were given a single oral dose of metformin hydrochloride sustained-release tablets (test preparation T, produced by Qingdao Huanghai Pharmaceutical Co., Ltd., specification: 0.5g) and metformin hydrochloride sustained-release tablets (reference preparation R, produced by Merck S.L., licensed by Merck Serono Ltd, trade name: Glucophage®SR, specification: 500mg) in the fasting/postprandial state. The absorption rate and extent of the test preparation and the reference preparation under fasting and postprandial conditions were investigated to evaluate whether the test preparation and the reference preparation were bioequivalent.

The main purpose of the study is to use the reference preparation of Febuxostat® (Febuxostat Tablets, Specification: 40mg) produced by Teijin Pharma Limited Iwakuni Pharmaceutical Factory as the reference preparation and the Febuxostat Tablets (Specification: 40mg) developed by Qingdao Huanghai Pharmaceutical Co., Ltd. as the test preparation, and to evaluate the bioequivalence of the two preparations under fasting and fed conditions through a single-center, randomized, open, two-period, crossover clinical trial. The secondary purpose of the study is to evaluate the safety of the test preparation Febuxostat Tablets (40mg) and the reference preparation Febuxostat Tablets (Febuxostat®) (40mg) in healthy subjects.