Huayu WU XI Pharmaceutical Co. Ltd.

Mirtazapine Tablets (trade name: Padison®, 30 mg/tablet) produced by Huayu (Wuxi) Pharmaceutical Co., Ltd. were used as the test preparation, and Mirtazapine Tablets (trade name: Remeron®, 30 mg/tablet) produced by N.V. Organon and packaged by Hangzhou Merck Pharmaceuticals Co., Ltd. were used as the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic behavior of mirtazapine tablets in healthy Chinese subjects was compared to evaluate the bioequivalence of the two preparations.

The pharmacokinetic parameters and relative availability of 0.25 mg pramipexole hydrochloride tablets produced by Huayu (Wuxi) Pharmaceutical Co., Ltd. and 0.25 mg pramipexole hydrochloride tablets produced by Boehringer Ingelheim were investigated, and the bioequivalence of 0.25 mg dose after meal administration was evaluated in humans, so as to provide a reference for the clinical evaluation and clinical use of pramipexole hydrochloride tablets.

The pharmacokinetic parameters and relative availability of pramipexole hydrochloride tablets (specifications: 1.0 mg/tablet and 0.25 mg/tablet) produced by Huayu (Wuxi) Pharmaceutical Co., Ltd. and Senforo (pramipexole hydrochloride tablets, specifications: 1.0 mg/tablet and 0.25 mg/tablet) produced by Boehringer Ingelheim were investigated. The human bioequivalence studies of fasting administration and postprandial administration were conducted for the 1.0 mg dose, and the human bioequivalence evaluation of fasting administration was conducted for the 0.25 mg dose, to provide a reference for the clinical evaluation and clinical use of pramipexole hydrochloride tablets.