[Translation] A single-center, open-label, randomized, two-formulation, two-sequence, two-period, self-crossover human bioequivalence study of a single oral dose of acetylcysteine tablets in Chinese healthy subjects under fasting and fed conditions
研究健康受试者空腹及餐后单次口服受试制剂乙酰半胱氨酸片(海南赛立克药业有限公司,规格:0.6g)与参比制剂乙酰半胱氨酸片(商品名:Fluimucil ®,规格:0.6g)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及餐后条件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 of the test preparation acetylcysteine tablets (Hainan Celic Pharmaceutical Co., Ltd., specification: 0.6g) and the reference preparation acetylcysteine tablets (trade name: Fluimucil ®, specification: 0.6g) after a single oral administration on an empty stomach or after a meal in healthy subjects, to evaluate the bioequivalence of the test preparation and the reference preparation when administered on an empty stomach or after a meal, and to observe the safety of the test preparation and the reference preparation in healthy subjects.