Hexinotai Pharmaceutical Technology (Shandong) Co., Ltd.

The loxoprofen sodium gel patch (test preparation, T, 100 mg/patch (14×10 cm2) containing 10 g) produced by Harbin Liqiang Pharmaceutical Co., Ltd. was compared with LOXONIN®PAP (reference preparation, R, generic name: loxoprofen sodium gel patch, 100 mg/patch (14×10 cm2) containing 10 g) produced by Lead Chemical Co., Ltd. of Japan in accordance with the relevant provisions of the bioequivalence study to evaluate the bioequivalence of the test preparation and the reference preparation in a single patch application in Chinese healthy adult subjects.

Primary objective: To compare the pharmacokinetic behavior of the test preparation loxoprofen sodium gel patch (manufacturer: Harbin Liqiang Pharmaceutical Co., Ltd.) and the reference preparation loxoprofen sodium gel patch (certificate holder: Lead Chemical Co., Ltd., trade name: LOXONIN®PAP) in healthy subjects after a single application of the test preparation loxoprofen sodium gel patch using pharmacokinetic parameters as the primary endpoint evaluation index, and to evaluate the bioequivalence of the two preparations. Secondary objective: To observe the safety of the test preparation and the reference preparation loxoprofen sodium gel patch, and to evaluate the adhesion and external irritation of the test preparation and the reference preparation loxoprofen sodium gel patch.