/ CompletedNot Applicable [Translation] Bioequivalence study of acetylcysteine granules in human body
采用单中心、随机、开放、两周期、自身交叉、单剂量给药设计进行空腹和餐后给药试验,评价湖南欧拉医药科技有限公司委托湖南新汇制药股份有限公司生产的乙酰半胱氨酸颗粒(乙酰半胱氨酸,规格:0.2 g)与海南赞邦制药有限公司生产的乙酰半胱氨酸颗粒(乙酰半胱氨酸,商品名:富露施®,规格:0.2 g)在中国健康受试者空腹和餐后状态下口服两制剂后的生物等效性及安全性,为该受试制剂注册申请提供依据。
[Translation] A single-center, randomized, open, two-period, self-crossover, single-dose administration design was used to conduct a fasting and postprandial administration trial to evaluate the bioequivalence and safety of acetylcysteine granules (acetylcysteine, specification: 0.2 g) produced by Hunan Oula Pharmaceutical Technology Co., Ltd. and Hunan Xinhui Pharmaceutical Co., Ltd. and acetylcysteine granules (acetylcysteine, trade name: Fulushi®, specification: 0.2 g) produced by Hainan Zanbang Pharmaceutical Co., Ltd. after oral administration of the two preparations in fasting and postprandial states in healthy Chinese subjects, so as to provide a basis for the registration application of the test preparation.
100 Clinical Results associated with Hunan Oula Medical Technology Co., Ltd.
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