[Translation] A randomized, open-label, two-formulation, single-dose, two-sequence, two-period, self-crossover formal bioequivalence study of acetylcysteine tablets 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乙酰半胱氨酸片(规格:0.6 g,浙江和沐康医药科技有限公司)与参比制剂乙酰半胱氨酸片(商品名(英文):Fluimucil®,规格:600 mg;ZAMBON Nederland B.V.)在人体内的药代动力学,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:观察空腹和餐后状态下口服受试制剂乙酰半胱氨酸片和参比制剂乙酰半胱氨酸片(商品名(英文):Fluimucil®)的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of a single oral dose of the test preparation acetylcysteine tablets (specification: 0.6 g, Zhejiang Hemukang Pharmaceutical Technology Co., Ltd.) and the reference preparation acetylcysteine tablets (trade name (English): Fluimucil®, specification: 600 mg; ZAMBON Nederland B.V.) in humans in the fasting/fed state, and to evaluate the bioequivalence of the two preparations in the fasting/fed state.
Secondary purpose of the study is to observe the safety of the test preparation acetylcysteine tablets and the reference preparation acetylcysteine tablets (trade name (English): Fluimucil®) in the fasting and fed state.