Jiangsu Yingke Biopharmaceutical Co., Ltd.

Primary objective: Using lidocaine tetracaine cream produced by Jiangsu Yingke Biopharmaceutical Co., Ltd. as the test preparation and lidocaine tetracaine cream (trade name: Pliaglis®) owned by DIFA COOPER S.P.A. as the reference preparation, the clinical equivalence of the two lidocaine tetracaine creams was evaluated in subjects who underwent local anesthesia of intact skin before superficial skin surgery in adults, with the clinical efficacy of the patients as the endpoint. Secondary objective: Evaluate the safety of lidocaine tetracaine cream test preparation and reference preparation (trade name: Pliaglis®) in subjects who underwent local anesthesia of intact skin before superficial skin surgery in adults.

The primary study objective was to compare the absorption rate and extent of the test formulation (leprocaine cream produced by Jiangsu Yingke Biopharmaceutical Co., Ltd.) and the reference formulation (leprocaine cream produced by Aspen Pharma Trading Limited, trade name: Emla®) in healthy adult subjects on an empty stomach, and to evaluate the bioequivalence of the test formulation and the reference formulation. The secondary study objective was to evaluate the safety of the test formulation of leprocaine cream and the reference formulation Emla® in healthy adult subjects in China.

The propofol emulsion injection (trade name: Diprivan®, specification: 20 ml: 200 mg) produced by Corden Pharma S.P.A. was used as the reference preparation, and the propofol emulsion injection (specification: 20 ml: 200 mg) produced by Jiangsu Yingke Biopharmaceutical Co., Ltd. was used as the test preparation. The pharmacokinetic characteristics of the two preparations were evaluated through a single-center, randomized, open, double-period, double-crossover design pharmacokinetic comparative study. At the same time, the pharmacodynamics and safety were observed to provide support for the registration application for the consistency evaluation of the test preparation.