[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-crossover study to evaluate the bioequivalence of loxoprofen sodium gel patch and reference formulation in healthy volunteers
主要目的:比较单次贴敷条件下,武汉法玛星制药有限公司生产的洛索洛芬钠凝胶贴膏(受试制剂T,规格:每贴含洛索洛芬钠(以C15H17NaO3计)100mg(面积14.0cm×10.0cm,含膏量10g))与LEAD CHEMICAL CO., LTD生产的洛索洛芬钠凝胶贴膏(参比制剂R,商品名:LOXONIN ®,规格:每贴含洛索洛芬钠(以C15H17NaO3计)100mg(面积14.0cm×10.0cm,含膏量10g))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,评价洛索洛芬钠凝胶贴膏的安全性、粘贴牢固度和皮肤反应性。
[Translation] Primary objective: To compare the differences in the extent and rate of absorption of loxoprofen sodium gel patch (test preparation T, specification: each patch contains 100 mg of loxoprofen sodium (calculated as C15H17NaO3) (area 14.0 cm×10.0 cm, paste content 10 g)) produced by Wuhan Farmaxing Pharmaceutical Co., Ltd. and loxoprofen sodium gel patch (reference preparation R, trade name: LOXONIN ®, specification: each patch contains 100 mg of loxoprofen sodium (calculated as C15H17NaO3) (area 14.0 cm×10.0 cm, paste content 10 g)) produced by LEAD CHEMICAL CO., LTD in healthy subjects under single application conditions. The statistical analysis of the main pharmacokinetic parameters was used to evaluate whether the two products were bioequivalent.
Secondary objective: To evaluate the safety, adhesion firmness and skin reactivity of loxoprofen sodium gel 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.