[Translation] A single-center, open-label, randomized, two-formulation, two-sequence, four-period, fully repeated crossover bioequivalence study of a single oral dose of erythromycin ethylsuccinate tablets in healthy Chinese subjects under fasting conditions
研究健康受试者空腹单次口服受试制剂琥乙红霉素片(西安利君制药有限责任公司,规格:400mg)与参比制剂琥乙红霉素片(Arbor pharmaceuticals LLC,规格:400mg)在吸收程度和速度方面是否存在差异,评价受试制剂和参比制剂在空腹状态下给药时的生物等效性,观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] To study whether there are differences in the extent and rate of absorption between the test preparation erythromycin ethylsuccinate tablets (Xi'an Lijun Pharmaceutical Co., Ltd., specification: 400 mg) and the reference preparation erythromycin ethylsuccinate tablets (Arbor pharmaceuticals LLC, specification: 400 mg) after a single oral administration on an empty stomach in healthy subjects, to evaluate the bioequivalence of the test preparation and the reference preparation when administered in the fasting state, and to observe the safety of the test preparation and the reference preparation in healthy subjects.