[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence pilot study of crisaborole ointment (specification: 2%, 30 g/tube) in Chinese healthy subjects under fasting condition
主要研究目的:观察中国健康受试者空腹状态下单次外用受试制剂克立硼罗软膏4g(规格:2%,30g/支)和参比制剂克立硼罗软膏4g(商品名:舒坦明®/Staquis®;规格:2%,30g/支;持证商:Anacor Pharmaceuticals Inc)后的药代动力学特征,初步评价空腹外用状态下两种制剂的生物等效性。
次要研究目的:观察空腹外用受试制剂克立硼罗软膏和参比制剂克立硼罗软膏(舒坦明®/Staquis®)在中国健康受试者中的安全性。
[Translation] The main purpose of the study is to observe the pharmacokinetic characteristics of the test preparation crisaborole ointment 4g (specification: 2%, 30g/tube) and the reference preparation crisaborole ointment 4g (trade name: Sutanming®/Staquis®; specification: 2%, 30g/tube; licensee: Anacor Pharmaceuticals Inc) after single topical application in Chinese healthy subjects under fasting state, and preliminarily evaluate the bioequivalence of the two preparations under fasting topical state.
Secondary purpose of the study is to observe the safety of the test preparation crisaborole ointment and the reference preparation crisaborole ointment (Sutantamine®/Staquis®) in Chinese healthy subjects after fasting topical application.