/ CompletedNot Applicable 健康受试者在空腹状态下单次外用克立硼罗软膏的人体生物等效性试验
[Translation] A human bioequivalence study of a single topical application of crisaborole ointment in healthy subjects in the fasting state
主要目的:以山东达冠医药科技有限公司提供的克立硼罗软膏为受试制剂,以Anacor Pharmaceuticals, Inc.持证的克立硼罗软膏(商品名:舒坦明®/Staquis®)为参比制剂,评估健康受试者在空腹状态下单次局部外用受试制剂和参比制剂的药代动力学特征,评价两种制剂的人体生物等效性。
次要目的:考察健康受试者使用受试制剂和参比制剂后的安全性。
[Translation] Main purpose: Using the crisaborole ointment provided by Shandong Daguan Pharmaceutical Technology Co., Ltd. as the test preparation and the crisaborole ointment (trade name: Staquis®/Staquis®) licensed by Anacor Pharmaceuticals, Inc. as the reference preparation, the pharmacokinetic characteristics of the test preparation and the reference preparation after single topical application in healthy subjects under fasting state were evaluated, and the bioequivalence of the two preparations in humans was evaluated.
Secondary purpose: To investigate the safety of the test preparation and the reference preparation after healthy subjects used them.
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