/ Not yet recruitingNot Applicable [Translation] Human bioequivalence study of crisaborole ointment in healthy subjects
主要目的:本试验旨在研究空腹条件下单次给予国药集团三益药业(芜湖)有限公司生产的克立硼罗软膏(规格:30g/支,2%)的药代动力学特征,并以Anacor Pharmaceuticals, LLC.持证的克立硼罗软膏(商品名:舒坦明®,规格:30g/支,2%)作为参比制剂,比较两制剂的药动学参数,以评价两制剂的人体生物等效性。
次要目的:研究克立硼罗受试制剂及参比制剂(商品名:舒坦明®,规格:30g/支,2%)在健康受试者中的安全性。
[Translation] Primary objective: This study aims to study the pharmacokinetic characteristics of a single dose of crisaborole ointment (specification: 30 g/tube, 2%) produced by Sinopharm Group Sanyi Pharmaceutical (Wuhu) Co., Ltd. under fasting conditions, and to compare the pharmacokinetic parameters of the two preparations with the certified crisaborole ointment (trade name: Sutanming®, specification: 30 g/tube, 2%) of Anacor Pharmaceuticals, LLC., to evaluate the bioequivalence of the two preparations in humans.
Secondary objective: To study the safety of the crisaborole test preparation and the reference preparation (trade name: Sutanming®, specification: 30 g/tube, 2%) in healthy subjects.
100 Clinical Results associated with Sinopharm Group Sanyi Pharmaceutical (Wuhu) Co. Ltd.
0 Patents (Medical) associated with Sinopharm Group Sanyi Pharmaceutical (Wuhu) Co. Ltd.
100 Deals associated with Sinopharm Group Sanyi Pharmaceutical (Wuhu) Co. Ltd.
100 Translational Medicine associated with Sinopharm Group Sanyi Pharmaceutical (Wuhu) Co. Ltd.