Hunan Heng Chang Pharmaceutical Group Co., Ltd.

A single-center, randomized, open-label, four-period, completely repeated crossover, single-dose administration design was used to conduct fasting and fed administration trials to evaluate the bioequivalence and safety of diclofenac sodium sustained-release tablets (diclofenac sodium, specification: 100 mg) licensed by Hunan Zhuangyuan Pharmaceutical Co., Ltd. and produced by Hunan Warner Pharmaceutical Co., Ltd. and diclofenac sodium sustained-release tablets (diclofenac sodium, trade name: VOLTARENE® LP, specification: 100 mg) licensed by NOVARTIS PHARMA S.A.S. and produced by Novartis Farma S.P.A. after oral administration of the two preparations in the fasting and fed states by participants of the Chinese Health Study, so as to provide a basis for the registration application of the test preparation.

Main purpose of the study: According to the relevant provisions of bioequivalence tests, Cefditoren Pivoxil Granules (Specification: 50mg (potency)/0.5g/bag) with Meiji Seika Pharma Co., Ltd. as the licensee was selected as the reference preparation, and the test preparation Cefditoren Pivoxil Granules (Specification: 50mg/0.5g) produced by Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. and licensed by Hunan Zhuangyuan Pharmaceutical Co., Ltd. was subjected to human bioequivalence test under the condition of postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under the condition of postprandial administration. Secondary purpose of the study: To observe the safety of oral administration of the test preparation Cefditoren Pivoxil Granules (Specification: 50mg/0.5g) and the reference preparation Cefditoren Pivoxil Granules (Specification: 50mg (potency)/0.5g/bag) in healthy volunteers.

(1) Primary objective: To evaluate the pharmacokinetic characteristics of the test and reference preparations after a single dose in healthy subjects in the fasting and postprandial state, using finasteride tablets provided by Hengchang (Guangzhou) New Drug Research Co., Ltd. as the test preparation (T) and finasteride tablets (trade name: Propecia®) licensed by Merck Sharp & Dohme Limited and produced by AIAC International Pharma LLC as the reference preparation (R), and to evaluate the bioequivalence of the two preparations in healthy subjects. (2) Secondary objective: To investigate the safety of the test and reference preparations in healthy subjects.