[Translation] A randomized, open, single-dose, two-sequence, two-period, double-crossover bioequivalence trial of crisaborole ointment for external use in Chinese healthy subjects under fasting conditions
主要研究目的:按有关生物等效性试验的规定,选择Anacor Pharmaceuticals, Inc.为持证商的克立硼罗软膏(商品名:舒坦明®;规格:2%)为参比制剂,对江苏万禾制药有限公司生产,南京恒道医药科技股份有限公司持证的受试制剂克立硼罗软膏(规格:2%)进行空腹外用给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,比较两种制剂在空腹给药条件下的生物等效性。
次要研究目的:观察健康志愿受试者空腹外用受试制剂克立硼罗软膏(规格:2%)和参比制剂克立硼罗软膏(商品名:舒坦明®,规格:2%)的安全性。
[Translation] Main purpose of study: According to the relevant provisions of bioequivalence test, Anacor Pharmaceuticals, Inc. is the licensee of crisaborole ointment (trade name: Sutanming®; specification: 2%) as the reference preparation, and the test preparation crisaborole ointment (specification: 2%) produced by Jiangsu Wanhe Pharmaceutical Co., Ltd. and licensed by Nanjing Hengdao Pharmaceutical Technology Co., Ltd. is used for fasting topical human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and to compare the bioequivalence of the two preparations under fasting administration conditions.
Secondary purpose of study: To observe the safety of the test preparation crisaborole ointment (specification: 2%) and the reference preparation crisaborole ointment (trade name: Sutanming®, specification: 2%) in fasting topical administration on healthy volunteers.