/ CompletedNot Applicable [Translation] Study on the bioequivalence of loxoprofen sodium patch in healthy volunteers
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] Main study objectives:
This study aims to study the pharmacokinetic characteristics of loxoprofen sodium patch (100 mg/patch (10 cm×14 cm)) produced by Nanjing Jiuxiao Pharmaceutical Co., Ltd. in healthy subjects after single fasting use; loxoprofen sodium patch (Lesong®, 100 mg/patch (10 cm×14 cm)) certified by LEAD CHEMICAL CO., LTD. was used as the reference preparation to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations and evaluate the bioequivalence of the two preparations in humans.
Secondary study objectives:
1) Evaluate the safety of the test preparation and the reference preparation in healthy subjects;
2) Evaluate the adhesion and skin irritation of the test preparation and the reference preparation during medication in healthy subjects.
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