[Translation] Randomized, open-label, single-dose, two-formulation, two-sequence, two-cycle, crossover bioequivalence trial of criborole ointment in healthy subjects under fasting state
主要目的:比较空腹单次给药条件下,湖北恒安芙林药业股份有限公司提供的克立硼罗软膏(规格:2%,30g/支,受试制剂)与Anacor Pharmaceuticals, Inc.持证,Pharmacia and Upjohn Company LLC生产的克立硼罗软膏(商品名:舒坦明®,规格:2%,30g/支,参比制剂)在健康受试者中吸收程度和速度的差异。通过主要药代动力学参数,评价两者是否生物等效,为受试制剂的注册申请提供依据。
次要目的:通过观察健康受试者单次敷用受试制剂和参比制剂后的安全性指标,评价克立硼罗软膏的安全性。
[Translation] Main purpose: To compare the criborole ointment (specification: 2%, 30g/tube, test preparation) provided by Hubei Heng'an Fulin Pharmaceutical Co., Ltd. and the licensed product of Anacor Pharmaceuticals, Inc. under the condition of single administration on an empty stomach. , the differences in the degree and speed of absorption of criborole ointment (trade name: Sutamine®, specification: 2%, 30g/tube, reference preparation) produced by Pharmacia and Upjohn Company LLC in healthy subjects. Through the main pharmacokinetic parameters, evaluate whether the two are bioequivalent and provide a basis for the registration application of the test preparation.
Secondary purpose: To evaluate the safety of criborole ointment by observing the safety indicators of healthy subjects after single application of the test preparation and reference preparation.