Harbin Pharmaceutical Group Co. Ltd. General Pharm Factory

Main research purpose: According to the relevant provisions of bioequivalence test, the norfloxacin tablets (trade name: BACCIDAL®, specification: 100mg/tablet) of which Xinglin Pharmaceutical Co., Ltd. is the licensee was selected as the reference preparation, and the test preparation norfloxacin capsules (specification: 0.1g/tablet) produced by Harbin Pharmaceutical Group Pharmaceutical Factory No. 6 and provided by Harbin Pharmaceutical Group Pharmaceutical Factory were tested for human bioequivalence under fasting administration. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see if they were within an acceptable range, and the bioequivalence of the two preparations under fasting administration conditions was evaluated. Secondary research purpose: To observe the safety of oral administration of the test preparation norfloxacin capsules (specification: 0.1g/tablet) and the reference preparation norfloxacin tablets (trade name: BACCIDAL®, specification: 100mg/tablet) by healthy volunteers.

This study aimed to investigate the pharmacokinetic characteristics of cefalexin tablets (0.25 g) developed by Harbin Pharmaceutical Group General Factory and produced by Harbin Sanjingmingshui Pharmaceutical Co., Ltd., after a single fasting and postprandial oral administration. Cefalexin tablets (0.25 g) produced by Teva Pharmaceuticals USA were used as a reference formulation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to evaluate their bioequivalence in humans.