Ningbo Hi Tech Zone Menovo Pharma Innov Res Insti 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 miglitol tablets (50 mg) developed by Ningbo Minova Pharmaceutical Innovation Research Institute Co., Ltd. and manufactured by Ningbo Minova Tiankang Pharmaceutical Co., Ltd., after a single fasting oral administration. Miglitol tablets (SEIBULE®, 50 mg) manufactured by Sanwa Chemical Research Institute Co., Ltd. were used as the reference formulation to compare the blood glucose ΔCSG,max and ΔAUEC0-4h after oral administration of the two formulations.

To evaluate the pharmacokinetic parameters of a single oral dose of the test formulation opiporpon capsules (50 mg, manufactured by Ningbo Minova Tiankang Pharmaceutical Co., Ltd.) and the reference formulation opiporpon capsules (ONGENTYS®, 50 mg; manufactured by Bial - Portela & Ca, SA) in healthy adult participants under fasting and postprandial conditions. Secondary objective: To evaluate the safety of the test formulation opiporpon capsules (50 mg) and the reference formulation opiporpon capsules (ONGENTYS®, 50 mg) in healthy adult participants.