[Translation] Formal trial of bioequivalence of erdosteine capsules in healthy subjects in a randomized, open-label, two-dose, single-dose, two-sequence, two-cycle, double-crossover fasted and fed state
主要研究目的:研究空腹/餐后状态下,单次口服厄多司坦胶囊受试制剂(和坦®,规格:0.3g ,浙江康乐药业股份有限公司)与参比制剂(ERDOTIN®,规格:0.3g,Edmond Pharma S.r.l.)在健康受试者体内的药代动力学行为,评价空腹/餐后状态下口服两种制剂的生物等效性。
[Translation] Main research purpose: To study the test preparation (Hetan®, specification: 0.3g, Zhejiang Kangle Pharmaceutical Co., Ltd.) and reference preparation (ERDOTIN®, specification) of erdosteine capsules in a single oral dose in fasting/postprandial state : 0.3 g, Edmond Pharma S.r.l.) pharmacokinetic behavior in healthy subjects to evaluate the bioequivalence of the two formulations orally in the fasted/fed state.