Zhejiang East Asia Pharmaceutical Co., Ltd.

Main study objectives To study the pharmacokinetics of the test formulation (T) Erdosteine Capsules (Specification: 0.3g, Zhejiang Dongya Pharmaceutical Co., Ltd.) and the reference formulation (R) Erdosteine Capsules (ERDOTIN®, Specification: 300mg, Edmond Pharma S.r.l.) in healthy adult subjects after a single oral administration in the fasting/fed state, and to evaluate the bioequivalence of the two formulations in the fasting/fed state. Secondary study objectives To evaluate the safety of the test formulation (T) Erdosteine Capsules and the reference formulation (R) Erdosteine Capsules (ERDOTIN®) in healthy subjects after oral administration in the fasting/fed state.

Main purpose: This study used Sumitomo Pharma Co., Ltd.'s certified mosapride citrate tablets [trade name: Gasmotin, specification: 5 mg (calculated as C21H25ClFN3O3?C6H8O7)] as the reference preparation. According to the relevant provisions of the bioequivalence test, the mosapride citrate tablets [specification: 5 mg (calculated as C21H25ClFN3O3?C6H8O7)] produced and provided by Zhejiang East Asia Pharmaceutical Co., Ltd. were used as the test preparation. The human bioequivalence test was conducted in the fasting/postprandial state to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Primary objective: To study the pharmacokinetics of the test preparation trimebutine maleate tablets (specification: 0.2g/tablet, produced by Zhejiang East Asia Pharmaceutical Co., Ltd.) and the reference preparation trimebutine maleate tablets (Debridat®, specification: 200mg/tablet; produced by FARMEA) in healthy subjects after single oral administration in fasting and fed state, and to evaluate the bioequivalence of the two preparations after oral administration in fasting and fed state. Secondary objective: To study the safety of the test preparation trimebutine maleate tablets and the reference preparation trimebutine maleate tablets in healthy subjects.