Gan&Lee Pharmaceuticals Shandong Co., Ltd.

Primary study objective: To evaluate the efficacy of bepedrucic acid tablets in patients with hyperlipidemia who are not well controlled by statins. Secondary study objective: To evaluate the efficacy, tolerability and safety of bepedrucic acid tablets in patients with hyperlipidemia who are not well controlled by statins.

The main purpose of the study is to study the pharmacokinetics of the test preparation Mesalazine Enteric-coated Sustained-release Capsules (Specification: 375 mg, licensed by Ganli Pharmaceutical Shandong Co., Ltd.) and the reference preparation Mesalazine Enteric-coated Sustained-release Capsules (Apriso®, Specification: 375 mg; licensed by Salix Pharmaceuticals, Inc.) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations after a single oral administration in the fasting and fed state. Secondary purpose of the study is to evaluate the safety of the test preparation Mesalazine Enteric-coated Sustained-release Capsules (Specification: 375 mg) and the reference preparation Mesalazine Enteric-coated Sustained-release Capsules (Apriso®, Specification: 375 mg) in healthy subjects.

Part A aims to evaluate the safety, tolerability and relative bioavailability of single-dose GZR18 tablets. Part B aims to evaluate the safety, tolerability and relative bioavailability of multiple continuous doses of GZR18 tablets. Part C aims to evaluate the effect of meal time on the pharmacokinetic parameters of GZR18 tablets.