[Translation] A single-center, randomized, open-label, two-period, self-crossover, single-dose administration design was conducted to compare the differences in the absorption extent and absorption rate of cloperidone hydrochloride tablets under postprandial administration conditions in healthy Chinese people, as well as the safety of cloperidone hydrochloride tablets.
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, two-period, self-crossover, single-dose design was used to compare the differences in absorption extent and absorption rate between cloperidone hydrochloride tablets (specification: 10 mg) produced by Chengdu Pharmaceutical Co., Ltd. of Diao Group and cloperidone hydrochloride tablets (trade name: HUSTAZOL®, specification: 10 mg) produced by Nipro ES Pharma Co., Ltd. in healthy Chinese people under the condition of postprandial administration, and to evaluate the safety of cloperidone hydrochloride tablets produced by Chengdu Pharmaceutical Co., Ltd. of Diao Group.