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Clinical Trials associated with PDX-02评估 PDX-02 外用给药后在中国健康受试者的安全性和耐受性及与氟比洛芬凝胶贴膏的比较药代动力学研究
[Translation] To evaluate the safety and tolerability of PDX-02 after topical administration in healthy Chinese subjects and to compare its pharmacokinetic profile with flurbiprofen gel patch
(1)比较PDX-02与氟比洛芬凝胶贴膏在中国健康成年受试者中经皮吸收后药物系统暴露的差异性;
(2)评估不同浓度的PDX-02单次局部给药在中国健康成年受试者中的安全性和耐受性及药物系统暴露的药代动力学特征;
(3)根据单次给药以及单日给药结果,初步选择合适的给药方法进行多次给药药代动力学比对试验,为后续临床研究推荐给药方案提供依据;
(4)考察大面积多次给予PDX-02在中国健康成年受试者中的安全性和耐受性及药物系统暴露的药代动力学特征。
[Translation] (1) Compare the differences in drug systemic exposure after percutaneous absorption between PDX-02 and flurbiprofen gel patch in healthy Chinese adult subjects;
(2) Evaluate the safety and tolerability of single topical administration of different concentrations of PDX-02 in healthy Chinese adult subjects and the pharmacokinetic characteristics of drug systemic exposure;
(3) Based on the results of single administration and single-day administration, preliminarily select appropriate administration methods for multiple administration pharmacokinetic comparison tests to provide a basis for recommending dosing regimens in subsequent clinical studies;
(4) Investigate the safety and tolerability of multiple administrations of PDX-02 over a large area in healthy Chinese adult subjects and the pharmacokinetic characteristics of drug systemic exposure.
100 Clinical Results associated with PDX-02
100 Translational Medicine associated with PDX-02
100 Patents (Medical) associated with PDX-02
100 Deals associated with PDX-02