Front Pharmaceutical PLC.

Primary Objective: Using healthy participants as subjects, this study compared the pharmacokinetics of diclofenac diethylamine emulsion 2% (50 g: 1.0 g, based on diclofenac sodium) manufactured and licensed by Fuyuan Pharmaceutical Co., Ltd., as the test formulation, and the bioequivalence of diclofenac diethylamine emulsion manufactured by Haleon CH SARL and licensed by Haleon Schweiz AG (trade name: Voltaren®, specification: 2% (50 g: 1.0 g, based on diclofenac sodium)) as the reference formulation. Secondary Objectives: (1) To observe the safety of the test formulation diclofenac diethylamine emulsion and the reference formulation diclofenac diethylamine emulsion in healthy participants; (2) To evaluate the skin reactivity of the test formulation diclofenac diethylamine emulsion and the reference formulation diclofenac diethylamine emulsion in healthy participants.

Using lidocaine-prilocaine aerosol (trade name: Fortacin®) licensed by Recordati Ireland Ltd. as the reference formulation and lidocaine-prilocaine aerosol provided by Fuyuan Pharmaceutical Co., Ltd. as the test formulation, a comparative pharmacokinetic (PK) study was conducted on healthy Chinese female subjects after a single dose to assess the safety of the reference and test formulations after a single dose in healthy Chinese female subjects.

Healthy volunteers were studied. A lidocaine gel patch (14 cm × 10 cm, 14 g of paste, 700 mg of lidocaine) from Fuyuan Pharmaceutical Co., Ltd. was used as the test formulation, while a 5% lidocaine gel patch (trade name: Lidoderm®) from Teikoku Pharma Usa Inc. was used as the reference formulation. The absorption rates and extents of the two formulations were compared in healthy volunteers, and the bioequivalence of the two formulations was evaluated. The safety, skin reactivity, and adhesion of the test and reference formulations of the lidocaine gel patch were evaluated in healthy Chinese volunteers.