[Translation] A randomized, open-label, two-formulation, single-dose, two-sequence, two-period, double-crossover bioequivalence study of erdosteine capsules in healthy subjects under fasting and fed conditions
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] The main purpose of the study is to study the pharmacokinetic behavior of the test formulation of erdosteine capsules (Hetan®, specification: 0.3g, Zhejiang Kangle Pharmaceutical Co., Ltd.) and the reference formulation (ERDOTIN®, specification: 0.3g, Edmond Pharma S.r.l.) in healthy subjects after a single oral administration under fasting/fed conditions, and to evaluate the bioequivalence of the two oral formulations under fasting/fed conditions.