Xinxiang Changle Pharmaceutical Co. Ltd.

The main purpose of the study is to study the pharmacokinetics of a single oral dose of the test preparation Bilastine Tablets (Specification: 20 mg, produced by Xinxiang Changle Pharmaceutical Co., Ltd.) and the reference preparation Bilastine Tablets (Specification: 20 mg, produced by A. Menarini Manufacturing Logistics and Services S.r.l.) in healthy subjects in the fasting state, and to evaluate the bioequivalence of the two preparations in the fasting state. The secondary purpose of the study is to evaluate the safety of the test preparation Bilastine Tablets (Specification: 20 mg) and the reference preparation Bilastine Tablets (Specification: 20 mg) in healthy subjects.

Main research purpose: According to the relevant provisions of bioequivalence tests, AstraZeneca AB was selected as the licensee, and dapagliflozin metformin extended-release tablets (trade name: Xigduo XR, specification: 10mg/1000mg) produced by AstraZeneca Pharmaceuticals LP was selected as the reference preparation. The test preparation dapagliflozin metformin extended-release tablets (specification: 10mg/1000mg) produced and provided by Xinxiang Changle Pharmaceutical Co., Ltd. was subjected to fasting and fed human bioequivalence tests to compare whether the absorption rate and degree of the drug in the test preparation were within an acceptable range with those of the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and fed administration conditions. Secondary study objective: To observe the safety of oral administration of the test preparation dapagliflozin metformin sustained-release tablets (specification: 10mg/1000mg) and the reference preparation dapagliflozin metformin sustained-release tablets (trade name: Xigduo XR, specification: 10mg/1000mg) to healthy volunteers.

To investigate whether there are differences in the extent and rate of absorption of the test preparation estazolam tablets (Xinxiang Changle Pharmaceutical Co., Ltd., specification: 1 mg/tablet) and the reference preparation estazolam tablets (trade name: EURODIN®; Teva Takeda Yakuhin Ltd., specification: 1 mg/tablet) after a single oral administration on an empty stomach or after a meal in healthy subjects, to evaluate the bioequivalence of the test preparation and the reference preparation when administered on an empty stomach or after a meal, and to observe the safety of the test preparation and the reference preparation in healthy subjects.