Ningbo Menovo Pharmaceutical Co., Ltd.

The study compared the pharmacokinetic characteristics of fenelazone tablets (test formulation T, strength: 20 mg) provided by Ningbo High-tech Zone Minova Pharmaceutical Innovation Research Institute Co., Ltd., and fenelazone tablets (reference formulation R, trade name: Keshenda®, strength: 20 mg) certified by Bayer AG, in a fasting state. The differences in pharmacokinetic parameters AUC and Cmax between the two formulations were compared to preliminarily assess the trend of bioequivalence between the two formulations.

This study aimed to investigate the pharmacokinetic characteristics of a 5-mg tablet of etogliflozin developed and produced by Ningbo Menuohua Tiankang Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal. Using a 5-mg tablet of etogliflozin licensed by Merck Sharp & Dohme B.V. and produced by Pfizer Manufacturing Deutschland GmbH as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.