双氯芬酸钠缓释片在健康受试者中的单剂量、随机、开放、两制剂空腹和餐后人体生物等效性试验
[Translation] A single-dose, randomized, open-label, two-dose bioequivalence study of diclofenac sodium extended-release tablets in healthy subjects after fasting and feeding
主要目的:以四川依科制药有限公司的双氯芬酸钠缓释片(规格:0.1g)为受试制剂,以Novartis Pharma GmbH持证的双氯芬酸钠缓释片(商品名:VOLTAREN®,规格:100mg)为参比制剂,按生物等效性试验的有关规定,考察两制剂在健康人体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: Diclofenac sodium sustained-release tablets (specification: 0.1g) of Sichuan Yike Pharmaceutical Co., Ltd. were used as the test preparation, and diclofenac sodium sustained-release tablets (trade name: VOLTAREN®, specification: 100mg) certified by Novartis Pharma GmbH were used as the reference preparation. According to the relevant provisions of the bioequivalence test, the bioequivalence of the two preparations in healthy humans was investigated.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.
恩格列净片在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of empagliflozin tablets in healthy volunteers under fasting/fed conditions
主要目的:本研究以四川依科制药有限公司持证的恩格列净片(规格:25mg)为受试制剂,Boehringer Ingelheim International GmbH持证的恩格列净片(商品名:Jardiance®,规格:25mg)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂和参比制剂在健康受试者体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main purpose: This study uses the empagliflozin tablets (specification: 25 mg) certified by Sichuan Yike Pharmaceutical Co., Ltd. as the test preparation and the empagliflozin tablets (trade name: Jardiance®, specification: 25 mg) certified by Boehringer Ingelheim International GmbH as the reference preparation to conduct a human bioequivalence test under fasting/postprandial conditions to evaluate the bioequivalence of the test preparation and the reference preparation in healthy subjects.
Secondary purpose: Observe the safety of the test preparation and the reference preparation in healthy subjects.
硝苯地平缓释片(II)在中国健康志愿者中空腹及餐后状态下的生物等效性试验
[Translation] Bioequivalence study of nifedipine sustained-release tablets (II) in Chinese healthy volunteers under fasting and fed conditions
观察硝苯地平缓释片(II)在中国健康受试者中单次口服给药后的硝苯地平体内动力学过程,估算相应的药代动力学参数,并以Bayer Hispania, S.L.持证的硝苯地平缓释片(II) (Adalat retard)为参比制剂,进行生物等效性评价。
次要目的:
观察硝苯地平缓释片(II)(受试制剂)和硝苯地平缓释片(II)(参比制剂)在健康人体中的安全性。
[Translation] To observe the in vivo kinetics of nifedipine after a single oral administration of nifedipine sustained-release tablets (II) in healthy Chinese subjects, estimate the corresponding pharmacokinetic parameters, and evaluate the bioequivalence of nifedipine sustained-release tablets (II) (Adalat retard) certified by Bayer Hispania, S.L. as the reference preparation.
Secondary objective:
To observe the safety of nifedipine sustained-release tablets (II) (test preparation) and nifedipine sustained-release tablets (II) (reference preparation) in healthy humans.
100 Clinical Results associated with Si Chuan Shu Zhong Zhi Yao You Xian Gong Si
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100 Deals associated with Si Chuan Shu Zhong Zhi Yao You Xian Gong Si
100 Translational Medicine associated with Si Chuan Shu Zhong Zhi Yao You Xian Gong Si