[Translation] A single-center, randomized, open-label, two-cycle crossover, two-preparation, two-sequence, single-dose design bioequivalence study of Criborole Ointment in Chinese healthy subjects under fasting conditions.
采用单中心、随机、开放、双周期交叉、两制剂、两序列、单剂量给药设计,比较空腹给药条件下,杭州朱养心药业有限公司提供的克立硼罗软膏(规格:2%)与Anacor Pharmaceuticals,Inc.持证的克立硼罗软膏(商品名:舒坦明®/Staquis®,规格:2%)在中国健康人群中吸收程度和吸收速度的差异,并评价杭州朱养心药业有限公司提供的克立硼罗软膏(规格:2%)的安全性。
[Translation] Using a single-center, random, open, two-cycle crossover, two preparations, two sequences, and single-dose dosing design, we compared the criborole ointment (specification: 2%) provided by Hangzhou Zhu Yangxin Pharmaceutical Co., Ltd. under fasting dosing conditions. Differences in the degree and rate of absorption between Anacor Pharmaceuticals, Inc.'s licensed criborole ointment (trade name: Sutamine®/Staquis®, specification: 2%) in healthy Chinese people, and evaluation of Hangzhou Zhu Yangxin Pharmaceutical Co., Ltd. The safety of criborole ointment (specification: 2%) provided by the company.