Chongqing Succeway Pharmaceutical Co., Ltd.

To investigate the pharmacokinetic characteristics of a single oral administration of one tablet of agomelatine tablets produced by Chongqing Saiwei Pharmaceutical Co., Ltd. (test preparation, strength: 25 mg) and a single oral administration of one tablet of agomelatine tablets certified by Les Laboratoires Servier (reference preparation, trade name: Valdoxan®, strength: 25 mg) in healthy subjects under fasting and postprandial conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.

In this study, pregabalin sustained-release tablets (specification: 165 mg) developed by Chongqing Saiwei Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant regulations of bioequivalence studies, pregabalin sustained-release tablets (specification: 165 mg, trade name: LYRICA® CR) produced by Pfizer Asia Manufacturing Pte Ltd were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions.

Main research purposes: Pirfenidone tablets (specification: 200mg, holder: Chongqing Savvy Pharmaceutical Co., Ltd.) provided by Chongqing Savvy Pharmaceutical Co., Ltd. were used as the test preparation, and were compared with pirfenidone licensed by Shionogi Pharmaceutical Co., Ltd. The relative bioavailability of ketone tablets (trade name: PIRESPA?, reference preparation) in healthy Chinese humans was compared, the pharmacokinetic parameters of the two preparations were analyzed, and the bioequivalence of the two preparations was evaluated. Secondary research purpose: Observe the safety of test and reference products (PIRESPA?) in healthy subjects.