[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover bioequivalence trial of loxoprofen sodium patches [100 mg/patch (10 cm × 14 cm)] in healthy Chinese subjects under fasting administration conditions.
主要研究目的:
本试验旨在研究健康受试者单次空腹使用南京九霄药业有限公司生产的洛索洛芬钠贴剂〔100 mg/贴(10 cm×14 cm)〕的药代动力学特征;以LEAD CHEMICAL CO., LTD. 持证的洛索洛芬钠贴剂〔乐松®,100 mg/贴(10 cm×14 cm)〕为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
次要研究目的:
1)评价受试制剂与参比制剂在健康受试者中的安全性;
2)评价受试制剂与参比制剂在健康受试者用药过程中的黏附性和皮肤刺激性。
[Translation] Primary Objective: This study aims to investigate the pharmacokinetic characteristics of a single fasting administration of loxoprofen sodium patches (100 mg/patch (10 cm × 14 cm)) manufactured by Nanjing Jiuxiao Pharmaceutical Co., Ltd. in healthy subjects. Loxoprofen sodium patches (Lesong®, 100 mg/patch (10 cm × 14 cm)) certified by LEAD CHEMICAL CO., LTD. were used as the reference formulation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to evaluate their bioequivalence in humans.
Secondary Objectives:
1) To evaluate the safety of the test formulation and the reference formulation in healthy subjects;
2) To evaluate the adhesion and skin irritation of the test formulation and the reference formulation during administration in healthy subjects.