[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-cycle, two-sequence, double-crossover fasting bioequivalence study of crisaborole ointment in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,比较在空腹状态下外用受试制剂克立硼罗软膏(持证商:福建省宝诺医药研发有限公司)与参比制剂克立硼罗软膏(持证商:Anacor Pharmaceuticals, Inc.,商品名:舒坦明®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要目的:(1)观察受试制剂克立硼罗软膏和参比制剂克立硼罗软膏在健康受试者中的安全性;(2)评价受试制剂克立硼罗软膏与参比制剂克立硼罗软膏对中国健康受试者的皮肤反应性。
[Translation] Primary objective: To compare the pharmacokinetic behavior of the test preparation crisaborole ointment (licensed by: Fujian Baonuo Pharmaceutical Research and Development Co., Ltd.) and the reference preparation crisaborole ointment (licensed by: Anacor Pharmaceuticals, Inc., trade name: Sutanming®) in healthy subjects after external application under fasting state, using pharmacokinetic parameters as the primary endpoint evaluation index, and to evaluate the bioequivalence of the two preparations.
Secondary objectives: (1) To observe the safety of the test preparation crisaborole ointment and the reference preparation crisaborole ointment in healthy subjects; (2) To evaluate the skin reactivity of the test preparation crisaborole ointment and the reference preparation crisaborole ointment in healthy Chinese subjects.