Hainan He Rui Pharmaceutical Co. Ltd.

The study investigated the skin irritation and sensitization of participants in a healthy trial who applied ketoprofen patches provided by Hainan Herui Pharmaceutical Co., Ltd. [the test formulation, specification: 40mg/patch (10cm×14cm)] and ketoprofen patches certified by Hisamitsu Pharmaceutical Co., Ltd. [the reference formulation, trade name: Mohrus, specification: 40mg/patch (10cm×14cm)] to provide a basis for the registration application of the test formulation.

Primary Objective: To compare the absorption extent and rate of absorption of the test formulation ketoprofen patch (40 mg/patch (10 cm × 14 cm)) provided by Hainan Herui Pharmaceutical Co., Ltd. and the reference formulation ketoprofen patch (trade name: Mohrus®; 40 mg/patch (10 cm × 14 cm)) certified by Hisamitsu Pharmaceutical Co., Ltd. in healthy participants under fasting conditions, and to evaluate the bioequivalence of the two formulations. Secondary Objectives: 1) To evaluate the adhesion of the test formulation and the reference formulation during administration to healthy participants; 2) To evaluate the safety of the test formulation and the reference formulation in healthy participants; 3) To evaluate the skin irritation of the test formulation and the reference formulation in healthy participants.

Primary objective: To evaluate the superiority of ketoprofen patches in the treatment of knee osteoarthritis, using placebo as a control; and to evaluate the clinical efficacy equivalence of ketoprofen patches in the treatment of knee osteoarthritis, using the original drug Mohrus (40 mg/patch, 10 cm × 14 cm) as a positive control. Secondary objective: To evaluate the safety of ketoprofen patches in the treatment of knee osteoarthritis.