[Translation] A single-center, single-dose, randomized, open-label, two-formulation, two-sequence, two-period, double-crossover, fasting and fed bioequivalence study of acetylcysteine oral solution in healthy subjects
主要研究目的:以海南赞邦制药有限公司为持证商的乙酰半胱氨酸颗粒(商品名:富露施®)为对照药物,以葵花药业集团(冀州)有限公司持有的乙酰半胱氨酸口服溶液为试验药物,通过单中心、随机、开放、单次给药、两制剂、两序列、两周期、双交叉设计临床研究来评价两种制剂在空腹及餐后状态下的人体生物等效性。
次要研究目的:观察试验药物和对照药物在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to use acetylcysteine granules (trade name: Fulushi®) licensed by Hainan Zanbang Pharmaceutical Co., Ltd. as the control drug and acetylcysteine oral solution owned by Sunflower Pharmaceutical Group (Jizhou) Co., Ltd. as the test drug. The two preparations are evaluated for their bioequivalence in the fasting and postprandial state through a single-center, randomized, open, single-dose, two-preparation, two-sequence, two-period, double-crossover design clinical study.
Secondary purpose of the study: To observe the safety of the test drug and the control drug in healthy Chinese subjects.