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Nonlinear Pharmacokinetics of Topical Flurbiprofen Gel in a Phase I Study Among Chinese Healthy Adults

Wending Xiao, Zhihong Zhu,Feifan Xie, Feiyan Liu,Zeneng Cheng

Pharmaceutical Research（2024）

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Abstract
PDX-02 (Flurbiprofen sodium) is a topical nonsteroidal anti-inflammatory drug in gel formulation for local analgesia and anti-inflammation. A Phase I clinical trial was conducted to assess the safety, tolerability, and pharmacokinetics of single and multiple doses of PDX-02 gel in Chinese healthy adults. The trial comprised three parts: (1) a single-dose ascending study with three dose levels (0.5
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Key words
autoinduction,flurbiprofen,nonlinear pharmacokinetics,skin metabolism,topical administration
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