[Translation] A single-center, randomized, open-label, two-cycle, self-crossover, single-dose administration design to compare the differences in the extent and rate of absorption of cloperidine hydrochloride tablets in healthy Chinese population under postprandial administration, as well as cloperidine hydrochloride film security.
采用单中心、随机、开放、双周期、自身交叉、单剂量给药设计比较餐后给药条件下,地奥集团成都药业股份有限公司生产的盐酸氯哌丁片(规格:10 mg)与Nipro ES Pharma Co.,Ltd.的盐酸氯哌丁片(商品名:HUSTAZOL®,规格:10 mg)在中国健康人群中吸收程度和吸收速度的差异,并评价地奥集团成都药业股份有限公司生产的盐酸氯哌丁片的安全性。
[Translation] A single-center, randomized, open-label, double-cycle, self-crossover, single-dose administration design was used to compare cloperidine hydrochloride tablets (specification: 10 mg) produced by Dio Group Chengdu Pharmaceutical Co., Ltd. The difference in absorption degree and absorption rate of Nipro ES Pharma Co., Ltd.'s cloperidine hydrochloride tablets (trade name: HUSTAZOL®, specification: 10 mg) in healthy Chinese population, and evaluation of Dio Group Chengdu Pharmaceutical Co., Ltd. The safety of the produced cloperidine hydrochloride tablets.