Anhui Anke Yuliangqing Pharmaceutical Co., Ltd.

Preliminary study: Main research purpose: Select the flurbiprofen gel patch (specification: 40mg) of Mikasa Pharmaceutical Co., Ltd. of Japan as the reference preparation, and conduct a human bioequivalence test on the flurbiprofen gel patch (specification: 40mg) (test preparation) produced by Anhui Anke Yu Liangqing Pharmaceutical Co., Ltd. on an empty stomach, estimate the pharmacokinetic characteristics of flurbiprofen in vivo after empty stomach topical application, and provide a certain reference basis for the design of formal trials. Secondary research objectives: 1. Observe the safety of healthy volunteers after topical application of the test preparation or reference preparation flurbiprofen gel patch. 2. Evaluate the adhesion and external irritation of the test preparation or reference preparation flurbiprofen gel patch for healthy volunteers during the trial. Formal test: Main research purpose: Select the flurbiprofen gel patch (specification: 40mg) of Mikasa Pharmaceutical Co., Ltd. of Japan as the reference preparation, and conduct a human bioequivalence test on the flurbiprofen gel patch (specification: 40mg) (test preparation) produced by Anhui Anke Yu Liangqing Pharmaceutical Co., Ltd., to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and compare the bioequivalence of the two preparations under fasting topical conditions. Secondary research purpose: 1. Observe the safety of healthy volunteers after topical application of the test preparation and the reference preparation flurbiprofen gel patch. 2. Evaluate the adhesion and external irritation of the test preparation or the reference preparation flurbiprofen gel patch for healthy volunteers during the trial.

Main research purpose: According to the relevant provisions of bioequivalence test, the flurbiprofen gel patch (trade name: Zepusi, specification: 40mg) with the license holder Mikasa Seiyaku Co., Ltd was selected as the reference preparation, and the test preparation flurbiprofen gel patch (specification: 40mg) produced and provided by Anhui Anke Yu Liangqing Pharmaceutical Co., Ltd. was used for human bioequivalence pre-test under external conditions to evaluate the pharmacokinetic characteristics of the test preparation and the reference preparation after fasting administration, so as to provide a certain reference basis for the design of formal trials. Secondary research objectives: 1. Observe the safety of Chinese healthy subjects after external use of the test preparation flurbiprofen gel patch (specification: 40mg) and the reference preparation flurbiprofen gel patch (trade name: Zepusi®, specification: 40mg). 2. To evaluate the adhesion and external irritation of the test preparation flurbiprofen gel patch (specification: 40 mg) or the reference preparation flurbiprofen gel patch (trade name: Zepus®, specification: 40 mg) in healthy volunteers during the trial.

Main research purpose: According to the relevant provisions of bioequivalence test, the flurbiprofen gel patch (trade name: Zepusi, specification: 40mg) with the license holder Mikasa Seiyaku Co., Ltd was selected as the reference preparation, and the test preparation flurbiprofen gel patch (specification: 40mg) produced and provided by Anhui Anke Yu Liangqing Pharmaceutical Co., Ltd. was subjected to human bioequivalence test under fasting 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 objectives: 1. Observe the safety of Chinese healthy subjects after external use of the test preparation flurbiprofen gel patch (specification: 40mg) and the reference preparation flurbiprofen gel patch (trade name: Zepusi, specification: 40mg). 2. 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: Zepus, specification: 40 mg) on healthy volunteers during the trial.