Zezheng Shanghai Biotechnology Co Ltd.

Main study objective: To investigate the palatability of amisulpride orodisintegrating tablets (specification: 200 mg, developed by Shanghai Zezheng Pharmaceutical Technology Co., Ltd.), aripiprazole orodisintegrating tablets (trade name: Bosiqing®, specification: 5 mg, licensed by Chengdu Kanghong Pharmaceutical Group Co., Ltd.), and risperidone orodisintegrating tablets (trade name: Xingzhi®, specification: 2 mg, licensed by Qilu Pharmaceutical Co., Ltd.) after a single oral administration under fasting conditions in healthy Chinese subjects.

Primary objective: Using the lidocaine prilocaine aerosol licensed by Recordati Ireland Ltd as the reference preparation and the lidocaine prilocaine aerosol produced by Shanghai Shanghai Pharmaceuticals Zhongxi Pharmaceutical Co., Ltd. as the test preparation, a multicenter, randomized, double-blind, active drug and placebo-controlled Phase III clinical study was conducted to evaluate the bioequivalence of the two preparations in humans using clinical endpoints as equivalence judgment indicators. Secondary objective: To evaluate the effectiveness of lidocaine prilocaine aerosol produced by Shanghai Shanghai Pharmaceuticals Zhongxi Pharmaceutical Co., Ltd. compared with its placebo in Chinese adult male patients with premature ejaculation (PE); to evaluate the safety of lidocaine prilocaine aerosol in Chinese adult male patients with premature ejaculation (PE).

The main purpose of the study is to use the lidocaine prilocaine aerosol (trade name: Fortacin) licensed by Recordati Ireland Ltd as the reference preparation and the lidocaine prilocaine aerosol developed by Zezheng (Shanghai) Biotechnology Co., Ltd. as the test preparation to evaluate the safety and tolerability of the reference preparation and the test preparation in single and continuous administration in healthy Chinese male subjects. Secondary purpose of the study: To evaluate the pharmacokinetic (PK) characteristics of the reference preparation and the test preparation in single and continuous administration in healthy Chinese male subjects.