Front Pharmaceutical PLC.

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.

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