[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, two-crossover bioequivalence and adhesion study to evaluate the transdermal administration of the test preparation loxoprofen sodium patch (specification: 100 mg/patch (10 cm×14 cm)) and the reference preparation loxoprofen sodium patch (Lesong®, specification: 100 mg/patch (10 cm×14 cm)) in healthy Chinese adult subjects under fasting conditions
主要研究目的:研究空腹条件下经皮单次给予受试制剂洛索洛芬钠贴剂(规格:100 mg/贴(10 cm×14 cm),重庆希尔安药业有限公司生产)与参比制剂洛索洛芬钠贴剂(乐松®,规格:100 mg/贴(10 cm×14 cm);LEAD CHEMICAL CO., LTD. HISAGANE PLANT生产)在中国健康成年受试者体内的药代动力学特征,评价两制剂的生物等效性。
次要研究目的:研究受试制剂洛索洛芬钠贴剂(规格:100 mg/贴(10 cm×14 cm))和参比制剂洛索洛芬钠贴剂(乐松®,规格:100 mg/贴(10 cm×14 cm))在中国健康成年受试者中的黏附性和安全性。
[Translation] Primary study objective: To study the pharmacokinetic characteristics of the test preparation loxoprofen sodium patch (specification: 100 mg/patch (10 cm×14 cm), produced by Chongqing Xi'an Pharmaceutical Co., Ltd.) and the reference preparation loxoprofen sodium patch (Lesong®, specification: 100 mg/patch (10 cm×14 cm); produced by LEAD CHEMICAL CO., LTD. HISAGANE PLANT) in healthy Chinese adult subjects after single percutaneous administration under fasting conditions, and to evaluate the bioequivalence of the two preparations.
Secondary study objective: To study the adhesion and safety of the test preparation loxoprofen sodium patch (specification: 100 mg/patch (10 cm×14 cm)) and the reference preparation loxoprofen sodium patch (Lesong®, specification: 100 mg/patch (10 cm×14 cm)) in healthy Chinese adult subjects.