Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.

This study aimed to investigate the pharmacokinetic characteristics of eltogliflozin tablets (5 mg) manufactured by Zhejiang Procon Pharmaceutical Co., Ltd., administered orally on an empty stomach and after a meal. Eltogliflozin tablets (Jianuotu®, 5 mg), manufactured by Pfizer Manufacturing Deutschland GmbH and licensed by Merck Sharp & Dohme B.V., 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 and to observe their safety in trial participants.

This study aimed to investigate the pharmacokinetic characteristics of a single oral dose of Ubenimex Capsules (10 mg) developed and produced by Zhejiang Proconyu Pharmaceutical Co., Ltd. under the experimental condition. Using Ubenimex Capsules (Bestatin®, 10 mg), licensed by Nippon Kayaku Co., Ltd. and manufactured by Nippon Kayaku Co., Ltd., as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, the bioequivalence of the two preparations in humans was evaluated, and the safety of the two preparations in study participants was observed.

Main study objectives: To study the pharmacokinetics of the test preparation Ezetimibe Atorvastatin Calcium Tablets (II) (Specifications: Ezetimibe 10mg/Atorvastatin Calcium 20mg (calculated as C33H35FN2O5), licensed by Zhejiang Proconyu Pharmaceutical Co., Ltd.) and the reference preparation Ezetimibe Atorvastatin Calcium Tablets (Atozet®, specifications: 10mg/20mg, licensed by Organon Healthcare GmbH) in healthy adult subjects after a single oral administration in the fed state, and to evaluate the bioequivalence of the two preparations after oral administration in the fed state. Secondary study objectives: To study the safety of the test preparation Ezetimibe Atorvastatin Calcium Tablets (II) and the reference preparation Ezetimibe Atorvastatin Calcium Tablets (Atozet®) in healthy adult subjects after a single oral administration in the fed state.