Changzhou Ruiming Pharmaceutical Co Ltd.

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.

Primary Study Objective: In accordance with relevant bioequivalence testing regulations, tranexamic acid tablets (trade name: Transamin®; strength: 250 mg) from Daiichi Sankyo Co., Ltd. were selected as the reference preparation. A human bioequivalence study was conducted with the test preparation, tranexamic acid tablets (250 mg), provided by Changzhou Ruiming Pharmaceutical Co., Ltd., under both fasting and fed conditions. The study aimed to compare the drug absorption rate and extent of the test preparation with those of the reference preparation to determine if they were within acceptable limits, and to evaluate the bioequivalence of the two preparations under both fasting and fed conditions. Secondary Study Objective: To observe the safety of oral administration of the test preparation (250 mg) and the reference preparation (trade name: Transamin®; strength: 250 mg) in healthy volunteers.