Qingdao Guohai Bio-Pharmaceutical Co., Ltd.

Main study objectives To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of Eperisone Hydrochloride Tablets (trade name: Yiyu, specification: 50mg, applicant: Qingdao Guohai Biopharmaceutical Co., Ltd.) and the reference formulation (trade name: Miaona®, specification: 50mg, licensee: Eisai (China) Pharmaceutical Co., Ltd.) after a single oral dose of Eperisone Hydrochloride Tablets in healthy Chinese adult subjects under fasting conditions. Secondary study objectives To study the safety of the test formulation of Eperisone Hydrochloride Tablets (trade name: Yiyu, specification: 50mg) and the reference formulation (trade name: Miaona®, specification: 50mg) in healthy Chinese adult subjects.

Main study objectives To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of Eperisone Hydrochloride Tablets (trade name: Yiyu, specification: 50mg, applicant: Qingdao Guohai Biopharmaceutical Co., Ltd.) and the reference formulation (trade name: Miaona®, specification: 50mg, licensee: Eisai (China) Pharmaceutical Co., Ltd.) after a single oral dose of Eperisone Hydrochloride Tablets in healthy Chinese adult subjects under fasting and postprandial conditions. Secondary study objectives To study the safety of the test formulation of Eperisone Hydrochloride Tablets (trade name: Yiyu, specification: 50mg) and the reference formulation (trade name: Miaona®, specification: 50mg) in healthy Chinese adult subjects.

1. To make a preliminary comparison of the pharmacokinetic profile of the test preparation and the reference preparation after oral administration in the fasting and postprandial states; 2. To preliminarily examine the rationality of the design of the blood sampling points, and verify the reproducibility and applicability of the analytical detection methods; 3. To obtain the intra-individual coefficient of variation of eperisone hydrochloride in healthy adult subjects in China, and to provide a theoretical basis for the number of subjects in the formal trial.