Maxmind Bio-Technology (Hainan) Co., Ltd.

Flurbiprofen gel patch [specification: each patch contains 40 mg of flurbiprofen (area 13.6 cm×10.0 cm, paste content 12 g); trade name: Zepolas®] produced by MIKASA SEIYAKU CO., LTD. was used as the reference preparation, and flurbiprofen gel patch [specification: each patch (area 13.6 cm×10.0 cm) contains 12 g of paste and 40 mg of flurbiprofen] developed by Shantou SEZ Meiji Pharmaceutical Co., Ltd. was used as the test preparation to evaluate the bioequivalence of the two preparations under topical use conditions in Chinese healthy subjects.

Main purpose: The loxoprofen sodium gel patch (100 mg/patch, trade name LOXONIN® PAP) of the licensed manufacturer LEAD CHEMICAL CO., LTD. was used as the reference preparation, and the loxoprofen sodium gel patch [each patch (14 cm×10 cm) contains 10 g of paste and 100 mg of loxoprofen sodium (calculated as C15H17NaO3)] developed by Meixiang Biotechnology (Hainan) Co., Ltd. was used as the test preparation. The bioequivalence of the two preparations under topical conditions in Chinese healthy subjects was evaluated through a single-center, randomized, open, single-dose, two-preparation, two-period, four-sequence, crossover design clinical trial. Secondary objectives: 1) To evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects; 2) To evaluate the adhesion of the test preparation and the reference preparation during the medication process in Chinese healthy subjects; 3) To evaluate the skin reactivity of the test preparation and the reference preparation in Chinese healthy subjects.

Main purpose: Using the flurbiprofen gel patch (40 mg/patch, trade name Zepusi®) of Mikasa Seiyaku Co., Ltd as the reference preparation and the flurbiprofen gel patch (40 mg/patch) developed by Meixiang Biotechnology (Hainan) Co., Ltd. as the test preparation, a single-center, randomized, open, single-dose, two-preparation, two-cycle, four-sequence, crossover clinical trial was conducted to evaluate the bioequivalence of the two preparations under topical conditions in Chinese healthy subjects. Secondary objectives: 1) Evaluate the safety of the test preparation and the reference preparation in Chinese healthy subjects; 2) Evaluate the adhesion of the test preparation and the reference preparation during the medication process in Chinese healthy subjects; 3) Evaluate the skin reactivity of the test preparation and the reference preparation in Chinese healthy subjects.