/ Active, not recruitingNot Applicable [Translation] Human bioequivalence study of mosapride citrate tablets
本试验旨在研究单次空腹和餐后口服浙江诺得药业有限公司研制、生产的枸橼酸莫沙必利片(5 mg)的药代动力学特征;以Sumitomo Pharma Co.,Ltd.持证、Sumitomo Pharma Co.,Ltd. Suzuka Plant生产的枸橼酸莫沙必利片(加斯清®,5 mg)为参比制剂,比较两制剂中药动学参数Cmax和AUC0-t,评价两制剂的人体生物等效性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of mosapride citrate tablets (5 mg) developed and manufactured by Zhejiang Nuode Pharmaceutical Co., Ltd., administered orally in both fasting and postprandial doses. Mosapride citrate tablets (Gasqing®, 5 mg), manufactured by Sumitomo Pharma Co., Ltd. and licensed by Sumitomo Pharma Co., Ltd. Suzuka Plant, were used as a reference formulation. The pharmacokinetic parameters Cmax and AUC0-t of the two formulations were compared to evaluate their bioequivalence in humans.
/ RecruitingNot Applicable [Translation] Bioequivalence study of oseltamivir phosphate granules in humans
本试验旨在研究空腹和餐后状态下单次口服浙江诺得药业有限公司研制、生产的磷酸奥司他韦颗粒﹝0.9 g(按C16H28N2O4计)﹞的药代动力学特征;以中外製薬株式会社持证的磷酸奥司他韦干糖浆〔Tamiflu®,3%(30 mg/g)〕为参比制剂,比较两制剂中药动学参数Cmax和AUC0-t,评价两制剂的人体生物等效性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of a single oral dose of oseltamivir phosphate granules (0.9 g, calculated as C16H28N2O4) manufactured by Zhejiang Nuode Pharmaceutical Co., Ltd., under fasting and postprandial conditions. Oseltamivir phosphate dry syrup (Tamiflu®, 3% (30 mg/g)) certified by Chugai Pharmaceutical Co., Ltd. was used as the reference formulation. The pharmacokinetic parameters Cmax and AUC0-t of the two formulations were compared to evaluate their bioequivalence in humans.
/ Active, not recruitingNot Applicable [Translation] Human bioequivalence study of candesartan medoxomil hydrochlorothiazide tablets (I)
本试验旨在研究健康试验参与者单次空腹口服浙江诺得药业有限公司研制、生产的坎地沙坦酯氢氯噻嗪片(I)(8mg/12.5mg)的药代动力学特征;以Cheplapharm Arzneimittel GmbH持证、Delpharm Novara S.r.l.生产的坎地沙坦酯氢氯噻嗪片(Blopress®,8mg/12.5mg)为参比制剂,比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性,并观察两制剂在健康试验参与者中的安全性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of candesartan medoxomil/hydrochlorothiazide tablets (I) (8 mg/12.5 mg) manufactured by Zhejiang Nuode Pharmaceutical Co., Ltd., after a single fasting oral administration to healthy participants. Candesartan medoxomil/hydrochlorothiazide tablets (Blopress®, 8 mg/12.5 mg), licensed by Cheplapharm Arzneimittel GmbH and manufactured by Delpharm Novara S.r.l., 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 healthy participants.
100 Clinical Results associated with Zhejiang NuoDe Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Zhejiang NuoDe Pharmaceutical Co., Ltd.
100 Deals associated with Zhejiang NuoDe Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Zhejiang NuoDe Pharmaceutical Co., Ltd.