Shandong Penglai Nuokang Pharmaceutical Co. Ltd.

Primary objective: To evaluate the effectiveness of the test preparation on adult male primary premature ejaculation patients using lidocaine prilocaine aerosol developed by Anhui Jiexi Pharmaceutical Co., Ltd. as the test preparation, and lidocaine prilocaine aerosol (trade name: Fortacin®) licensed by Recordati Ireland Ltd. as the reference preparation, and placebo as the control. Secondary objective: To evaluate the effectiveness and safety of lidocaine prilocaine aerosol test preparation and reference preparation (trade name: Fortacin®) in adult male primary premature ejaculation subjects.

Primary objective Using the lidocaine prilocaine aerosol (trade name: Fortacin®) licensed by Recordati Ireland Ltd. as the reference preparation and the lidocaine prilocaine aerosol provided by Anhui Jiexi Pharmaceutical Co., Ltd. as the test preparation, a comparative study of the pharmacokinetic (PK) characteristics of a single dose in healthy Chinese male subjects was conducted. Secondary objective To evaluate the safety of the reference preparation and the test preparation in a single dose in healthy Chinese male subjects.

Main purpose Using the lidocaine prilocaine aerosol (trade name: Fortacin®) licensed by Recordati Ireland Ltd. as the reference preparation and the lidocaine prilocaine aerosol provided by Anhui Jiexi Pharmaceutical Co., Ltd. as the test preparation, a comparative study of the pharmacokinetic (PK) characteristics of single-dose in healthy Chinese female subjects was conducted. Secondary purpose To evaluate the safety of single-dose in healthy Chinese female subjects between the reference preparation and the test preparation.