Hunan Qianjin Xieli Pharmaceutical Co., Ltd.

The main purpose of the study is to use the Eperisone Hydrochloride Tablets (50mg, trade name: Miaona®) certified by Eisai (China) Pharmaceutical Co., Ltd. as the reference preparation and the Eperisone Hydrochloride Tablets (50mg) produced by Hunan Qianjin Xieli Pharmaceutical Co., Ltd. as the test preparation. The two preparations are evaluated for their bioequivalence in the fasting and postprandial state in healthy Chinese subjects through a single-center, randomized, open, single-dose, two-sequence, four-period, completely repeated crossover design clinical study. Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Primary objective: To evaluate the bioequivalence of the test preparation indobufen tablets produced by Hunan Qianjin Xieli Pharmaceutical Co., Ltd. and the reference preparation indobufen tablets (Ibustrin®) produced by Pfizer Italia S.r.l. in healthy subjects after oral administration in fasting and fed state. Secondary objective: To observe the safety of the test preparation indobufen tablets and the reference preparation indobufen tablets (Ibustrin®) in healthy subjects.

Bisoprolol Amlodipine Tablets developed by Hunan Qianjin Xieli Pharmaceutical Co., Ltd. were used as the test preparation, and Bisoprolol Amlodipine Tablets (trade name: Kangxinan®) licensed by Merck Kft and produced by Egis Pharmaceuticals PLC were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration under fasting and postprandial conditions were investigated to evaluate whether the two preparations were bioequivalent.