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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date01 Jan 1995 |
硝苯地平缓释片(I)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 (I) in fasting and postprandial conditions in Chinese healthy volunteers
(1)主要目的
观察硝苯地平缓释片(I)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 公司(バイエル薬品株式会社)生产的硝苯地平缓释片(I)(Adalat®-L10)为参比制剂,进行生物等效性评价。
(2)次要目的
观察硝苯地平缓释片(I)(受试制剂)和硝苯地平缓释片(I)(参比制剂)在健康人体中的安全性。
[Translation] (1) Main purpose
To observe the in vivo kinetics of nifedipine sustained-release tablet (I) after a single oral administration of nifedipine in Chinese healthy subjects, estimate the corresponding pharmacokinetic parameters, and use Bayer Company (バイエル喬pin Co., Ltd.) ) produced nifedipine sustained-release tablets (I) (Adalat®-L10) as the reference preparation for bioequivalence evaluation.
(2) Secondary purpose
To observe the safety of nifedipine sustained-release tablet (I) (test preparation) and nifedipine sustained-release tablet (I) (reference preparation) in healthy subjects.
[Translation] Human bioequivalence test of ornidazole tablets under fasting and postprandial conditions
主要研究目的
考察健康受试者在空腹及餐后条件下,单次口服1片由山东鲁抗医药集团赛特有限责任公司生产的奥硝唑片(受试制剂T,规格:0.5g)与相同条件下单次口服1片由OrPha Swiss GmbH持证的奥硝唑片(参比制剂R,商品名:Tiberal®,规格:0.5g)的药动学特征,评价两制剂的生物等效性,为该受试制剂一致性评价提供依据。
次要研究目的
观察健康受试者在空腹及餐后条件下单次口服0.5g的受试制剂奥硝唑片(规格:0.5g)与参比制剂奥硝唑片(商品名:Tiberal®,规格:0.5g)的安全性。
[Translation] Main research purpose
Under the conditions of fasting and postprandial, healthy subjects were observed to take a single oral ornidazole tablet (test preparation T, specification: 0.5g) produced by Shandong Lukang Pharmaceutical Group Saite Co., Ltd. and under the same conditions. The pharmacokinetic characteristics of a single oral ornidazole tablet (reference preparation R, trade name: Tiberal®, strength: 0.5g) certified by OrPha Swiss GmbH, and the bioequivalence of the two preparations were evaluated, as the Provide the basis for the consistency evaluation of the tested preparations.
Secondary research purpose
Observe healthy subjects taking 0.5g of test preparation ornidazole tablets (specification: 0.5g) and reference preparation ornidazole tablets (trade name: Tiberal®, specification: 0.5g) under fasting and postprandial conditions. ) security.
格列吡嗪片在中国健康受试者空腹和餐后状态下 单中心、随机、开放、双周期、双交叉设计的生物等效性试验
[Translation] Bioequivalence trial of glipizide tablets in Chinese healthy subjects in fasting and fed state in a single-center, randomized, open-label, two-cycle, two-crossover design
1.主要目的:评价山东鲁抗医药集团赛特有限责任公司生产的格列吡嗪片(规 格:5mg/片)与原研药格列吡嗪片(规格:5mg/片,商品名:Glucotrol®,Pfizer Inc.生产)在健康成年受试者空腹和餐后情况下单次口服给药的人体生物等效 性。2.次要目的:评价格列吡嗪片在健康成年受试者中的安全性。
[Translation] 1. Main purpose: To evaluate the glipizide tablets (specification: 5mg/tablet) produced by Shandong Lukang Pharmaceutical Group Saite Co., Ltd. and the original research drug glipizide tablets (specification: 5mg/tablet, trade name: Glucotrol® , produced by Pfizer Inc.) human bioequivalence of a single oral dose in healthy adult subjects under fasted and fed conditions. 2. Secondary objective: To evaluate the safety of glipizide tablets in healthy adult subjects.
100 Clinical Results associated with Shandong Lukang Pharmaceutical Group Saite Co., Ltd.
0 Patents (Medical) associated with Shandong Lukang Pharmaceutical Group Saite Co., Ltd.
100 Deals associated with Shandong Lukang Pharmaceutical Group Saite Co., Ltd.
100 Translational Medicine associated with Shandong Lukang Pharmaceutical Group Saite Co., Ltd.