/ 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.
/ Active, not recruitingNot Applicable [Translation] Human bioequivalence study of dapagliflozin metformin extended-release tablets (I)
本试验旨在研究健康研究参与者单次空腹口服浙江诺得药业有限公司研制、生产的达格列净二甲双胍缓释片(I)(10 mg/1000 mg)的药代动力学特征;以AstraZeneca Pharmaceuticals LP生产的达格列净二甲双胍缓释片(Ⅰ)(安达释®,10 mg/1000 mg)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研究参与者中的安全性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of a single fasting oral dose of dapagliflozin metformin extended-release tablets (I) (10 mg/1000 mg) manufactured by Zhejiang Nuode Pharmaceutical Co., Ltd. Dapagliflozin metformin extended-release tablets (I) (AdaSure®, 10 mg/1000 mg) manufactured by AstraZeneca Pharmaceuticals LP was 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 study participants.
/ RecruitingNot Applicable [Translation] Human bioequivalence study of telmisartan 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、生产的替米沙坦片(80 mg)的药代动力学特征;以Boehringer Ingelheim International GmbH持证、Boehringer Ingelheim Hellas Single Member S.A.生产的替米沙坦片(Micardis®,80 mg)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。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of telmisartan tablets (80 mg) developed and manufactured by Zhejiang Nuode Pharmaceutical Co., Ltd., administered orally on an empty stomach and after a meal. Telmisartan tablets (Micardis®, 80 mg), manufactured by Boehringer Ingelheim Hellas Single Member S.A. and licensed by Boehringer Ingelheim International GmbH, 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.
100 Clinical Results associated with Zhejiang NuoDe Pharmaceutical Co., Ltd.
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100 Deals associated with Zhejiang NuoDe Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Zhejiang NuoDe Pharmaceutical Co., Ltd.