[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受试制剂(T)厄多司坦胶囊(规格:0.3g ,浙江东亚药业股份有限公司)与参比制剂(R)厄多司坦胶囊(ERDOTIN®,规格:300mg,Edmond Pharma S.r.l.)在健康成年受试者体内的药代动力学,评价空腹/餐后状态口服两种制剂的生物等效性。
次要研究目的
评价健康受试者在空腹/餐后状态下口服受试制剂(T)厄多司坦胶囊和参比制剂(R)厄多司坦胶囊(ERDOTIN®)后的安全性。
[Translation] 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.