Hunan Xiangzhong Pharmaceutical Co., Ltd.

Main purpose: Using oxcarbazepine tablets provided by Hunan Xiangzhong Pharmaceutical Co., Ltd. as the test preparation, according to the relevant provisions of the bioequivalence test, the absorption rate and degree of oxcarbazepine tablets (trade name: Trileptin®, reference preparation) produced by Novartis Farma S.p.A. were compared in healthy humans, and the human bioequivalence of the two preparations was investigated. Secondary purpose: To observe the safety of the test preparation oxcarbazepine tablets and the reference preparation oxcarbazepine tablets (trade name: Trileptin®) in healthy subjects.

Primary objective: To evaluate the bioequivalence of the test preparation agomelatine tablets (strength: 25 mg, manufacturer: Hunan Xiangzhong Pharmaceutical Co., Ltd.) and the reference preparation agomelatine tablets (Videosin®, strength: 25 mg) of which Les Laboratoires Servier is the licensee in healthy male and female subjects under fasting/fed conditions. Secondary objective: To observe the safety of the test preparation agomelatine tablets and the reference preparation agomelatine tablets (Videosin®) in healthy subjects.

The aim of this study was to investigate the pharmacokinetic characteristics of oxcarbazepine tablets (0.3 g) developed and produced by Hunan Xiangzhong Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Oxcarbazepine tablets (Trilep®, 0.3 g) produced by Novartis Farma S.p.A. were used as the reference preparation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.