Changzhou Ruiming Pharmaceutical Co Ltd.

Primary Objective: In accordance with relevant bioequivalence testing regulations, tamsulosin hydrochloride extended-release capsules (trade name: Harle®, specification: 0.2 mg), certified by Astellas Pharma (China) Co., Ltd., were selected as the reference formulation. A human bioequivalence study was conducted on the test formulation, tamsulosin hydrochloride extended-release capsules (specification: 0.2 mg), manufactured and supplied by Changzhou Ruiming Pharmaceutical Co., Ltd., under fasting and postprandial administration conditions. The study compared the absorption rate and extent of absorption of the drug in the test formulation with the reference formulation to determine if the differences were within acceptable ranges, and evaluated the bioequivalence of the two formulations under fasting and postprandial administration conditions. Secondary Objective: To observe the safety of oral administration of the test formulation, tamsulosin hydrochloride extended-release capsules (specification: 0.2 mg), and the reference formulation, tamsulosin hydrochloride extended-release capsules (trade name: Harle®, specification: 0.2 mg), in healthy participants.

In accordance with the relevant regulations for bioequivalence testing, tranexamic acid tablets (trade name: Transamin®; specification: 250mg) from DAIICHI SANKYO CO.,LTD. (Daiichi Sankyo Co., Ltd.) were selected as the reference formulation. A human bioequivalence study was conducted on the test formulation tranexamic acid tablets (specification: 250mg) provided by Changzhou Ruiming Pharmaceutical Co., Ltd. under fasting administration conditions. The differences in the absorption rate and extent of absorption of the drug in the test formulation and the reference formulation were compared to determine whether they were within acceptable ranges, thus evaluating the bioequivalence of the two formulations under fasting administration conditions.

The primary study objective was to compare the relative bioavailability of 5 mg levamlodipine maleate tablets (developed by Changzhou Ruiming Pharmaceutical Co., Ltd.) with that of amlodipine besylate tablets (10 mg, reference preparation, trade name: Norvasc®) produced by Pfizer Inc. in healthy volunteers, in accordance with relevant bioequivalence study regulations, to investigate the bioequivalence of the two formulations. The secondary study objective was to observe the safety of the test formulation, 5 mg levamlodipine maleate tablets, and the reference formulation, amlodipine besylate tablets (trade name: Norvasc®), in healthy volunteers.