[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-crossover study to evaluate the bioequivalence of loxoprofen sodium patch and reference formulation in healthy volunteers
主要目的:比较单次贴敷条件下,石家庄探索医药科技有限公司提供的洛索洛芬钠贴剂(受试制剂T,规格:100mg/贴(10cm×14cm))与LEAD CHEMICAL CO., LTD. HISAGANE PLANT生产的洛索洛芬钠贴剂(参比制剂R,商品名:乐松®,规格:100mg/贴(10cm×14cm))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的统计分析,评价两者是否生物等效。
次要目的:通过观察健康受试者单次贴敷受试制剂和参比制剂后的安全性指标和不同时点的粘贴牢固度、皮肤反应性评分,评价洛索洛芬钠贴剂的安全性、粘贴牢固度和皮肤反应性。
[Translation] Primary objective: To compare the differences in absorption extent and rate of loxoprofen sodium patch (test preparation T, specification: 100 mg/patch (10 cm×14 cm)) provided by Shijiazhuang Exploration Pharmaceutical Technology Co., Ltd. and loxoprofen sodium patch (reference preparation R, trade name: Lesong®, specification: 100 mg/patch (10 cm×14 cm)) produced by LEAD CHEMICAL CO., LTD. HISAGANE PLANT in healthy subjects under single application conditions. Statistical analysis of the main pharmacokinetic parameters was used to evaluate whether the two were bioequivalent.
Secondary objective: To evaluate the safety, adhesion firmness and skin reactivity of loxoprofen sodium patch by observing the safety indicators and adhesion firmness and skin reactivity scores at different time points after single application of the test preparation and reference preparation in healthy subjects.