Lindmik Pharmaceutical (Suzhou) Co., Ltd.

Main research purpose: According to the relevant provisions of bioequivalence test, the loxoprofen sodium gel patch (trade name: LOXONIN PAP®, specification: containing 100 mg of loxoprofen sodium) of the licensee LEAD CHEMICAL CO., LTD. was selected as the reference preparation, and the test preparation loxoprofen sodium gel patch (specification: containing 100 mg of loxoprofen sodium) produced by Leming Pharmaceutical (Suzhou) Co., Ltd. was subjected to human bioequivalence test under external use conditions to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under external use conditions. Secondary research purpose: To observe the safety of the test preparation loxoprofen sodium gel patch (specification: containing 100 mg of loxoprofen sodium) and the reference preparation loxoprofen sodium gel patch (trade name: LOXONIN PAP®, specification: containing 100 mg of loxoprofen sodium) after external use in healthy Chinese subjects. During the test, the adhesion and external irritation were evaluated.

Primary objective: Flurbiprofen gel patch (trade name: Zepusi, specification: 40 mg; Mikasa Pharmaceutical Co., Ltd., Japan) was selected as the reference preparation, and the test preparation flurbiprofen gel patch (specification: 40 mg) produced by Leming Pharmaceutical (Suzhou) Co., Ltd. was tested for human bioequivalence under external use conditions to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under external use conditions. Secondary objective: To observe the safety of Chinese healthy subjects after external use of the test preparation flurbiprofen gel patch (specification: 40 mg) and the reference preparation flurbiprofen gel patch (trade name: Zepusi, specification: 40 mg). To evaluate the adhesion and external irritation of the test preparation flurbiprofen gel patch (specification: 40 mg) and the reference preparation flurbiprofen gel patch (trade name: Zepusi, specification: 40 mg) in healthy volunteers during the trial.

Primary objective: To study the pharmacokinetic characteristics of the test preparation flurbiprofen gel patch (specification: 40 mg, Leming Pharmaceutical (Suzhou) Co., Ltd.) and the reference preparation flurbiprofen gel patch (Zepce®, specification: 40 mg; Mikasa Pharmaceutical Co., Ltd., Japan) in healthy subjects after a single administration under topical conditions, and to evaluate the bioequivalence of the two preparations under topical conditions. Secondary objectives: 1. To study the safety of the test preparation flurbiprofen gel patch (specification: 40 mg) and the reference preparation flurbiprofen gel patch (Zepce®) (specification: 40 mg) in healthy subjects. 2. To study the adhesion of the test preparation flurbiprofen gel patch (specification: 40 mg) and the reference preparation flurbiprofen gel patch (Zepce®) (specification: 40 mg) in healthy subjects.