[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of acetylcysteine oral solution in Chinese healthy subjects under fasting and fed conditions
主要研究目的:
考察健康受试者在空腹及餐后条件下单次口服30mL由南京艾德加生物制药科技有限公司提供的乙酰半胱氨酸口服溶液(受试制剂,规格:200mL:4g)与单次口服3袋由海南赞邦制药有限公司持证的乙酰半胱氨酸颗粒【参比制剂,商品名:富露施®;规格:0.2g(以乙酰半胱氨酸计)】的药动学特征,评价两制剂间的生物等效性和安全性,为该受试制剂注册申请提供依据。
次要研究目的:
观察健康受试者在空腹及餐后条件下单次口服受试制剂乙酰半胱氨酸口服溶液(规格:200mL:4g)与参比制剂乙酰半胱氨酸颗粒(商品名:富露施®,规格:0.2g)的安全性。
[Translation] Main study objectives:
To investigate the pharmacokinetic characteristics of a single oral administration of 30 mL of acetylcysteine oral solution (test preparation, specification: 200 mL: 4 g) provided by Nanjing Aidejia Biopharmaceutical Technology Co., Ltd. and a single oral administration of 3 bags of acetylcysteine granules (reference preparation, trade name: Fulushi®; specification: 0.2 g (in terms of acetylcysteine)) certified by Hainan Zanbang Pharmaceutical Co., Ltd. in healthy subjects under fasting and postprandial conditions, to evaluate the bioequivalence and safety between the two preparations, and to provide a basis for the registration application of the test preparation.
Secondary study objectives:
To observe the safety of a single oral administration of the test preparation acetylcysteine oral solution (specification: 200 mL: 4 g) and the reference preparation acetylcysteine granules (trade name: Fulushi®, specification: 0.2 g) in healthy subjects under fasting and postprandial conditions.