Zhejiang Yuanlijian Pharmaceutical Co., Ltd.

The Cinipride Tartrate Tablets (Specification: 1 mg) developed by Zhejiang Yuanlijian Pharmaceutical Co., Ltd. were used as the test preparation, and the Cinipride Tartrate Tablets (trade name: Cidine®/Cidine®, specification: 1 mg) from the licensed manufacturer Almirall, S.A. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent. At the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Rebamipide tablets (100 mg) produced by Zhejiang Yuanlijian Pharmaceutical Co., Ltd. was used as the test preparation, and Mucosta® (100 mg) marketed by Otsuka Pharmaceutical Co., Ltd. was used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after single administration in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent, and the safety of the two preparations in healthy subjects was evaluated.

The time course of blood drug concentration after a single oral dose of the test preparation rebamipide capsules (0.1 g/capsule) was observed in healthy subjects on an empty stomach, and the corresponding pharmacokinetic parameters were estimated. The blood drug concentration was compared with the reference preparation rebamipide tablets (0.1 g/tablet, trade name: Mogusida) to evaluate the relative bioavailability and bioequivalence.