Chongqing Succeway Pharmaceutical Co., Ltd.

Primary study objective: To evaluate the bioequivalence of single oral administration of carbodiol extended-release tablets produced by Chongqing Saiwei Pharmaceutical Co., Ltd. and carbodiol extended-release tablets (trade name: Sinemet®) certified by MSD Sharp & Dohme GmbH in healthy Chinese population after fasting and postprandial administration. Secondary study objective: To evaluate the safety of the test and reference formulations in healthy Chinese adult participants. To evaluate the safety of the test and reference formulations after single oral administration on an empty stomach/postprandial basis in healthy Chinese study participants.

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.