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MechanismCOX-2 inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date31 Dec 1998 |
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MechanismTubulin inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date27 Nov 1995 |
[Translation] Comparative study on the pharmacokinetics of celecoxib tablets (Ⅰ) in human subjects
主要目的:本研究采用随机开放、四序列、四周期、空腹及餐后给药设计,比较空腹及餐后条件下北京德立赛纳医药科技有限公司研制、安徽四环科宝制药有限公司生产的塞来昔布片(I)与Pfizer Pharmaceuticals LLC生产的塞来昔布胶囊(西乐葆®)在健康受试者体内暴露量的差异。并分别评价空腹/餐后条件下塞来昔布片(I)与塞来昔布胶囊的食物效应。
次要目的:观察健康受试者单次口服试验药物和对照药物的安全性。
[Translation] Primary Objective: This study used a randomized, open-label, four-sequence, four-period, fasting and fed dosing design to compare the exposure of celecoxib tablets (I) developed by Beijing Delishena Pharmaceutical Technology Co., Ltd. and manufactured by Anhui Sihuan Kebao Pharmaceutical Co., Ltd., and celecoxib capsules (Celebrex®) manufactured by Pfizer Pharmaceuticals LLC, under fasting and fed conditions in healthy volunteers. The food effect of celecoxib tablets (I) and celecoxib capsules under fasting and fed conditions was also evaluated.
Secondary Objective: To observe the safety of a single oral dose of the test drug and the control drug in healthy volunteers.
多西他赛注射用浓缩液(自乳化型)的人体药代动力学对比研究
[Translation] Comparative study on the pharmacokinetics of docetaxel concentrate for injection (self-emulsifying type) in humans
主要目的:以北京德立英捷医药科技有限公司研制、生产的多西他赛注射用浓缩液(自乳化型)(规格:1mL:20mg)为受试制剂,以Sanofi-Aventis Deutschland GmbH公司生产的多西他赛注射液(规格:0.5mL:20mg,泰索帝®)为参比制剂,按照生物等效性试验的有关规定进行体内药动学对比研究,考察多西他赛在诊断为恶性肿瘤且准备接受多西他赛化疗方案患者中的药代动力学行为,评价两种制剂的生物等效性。
次要目的:研究受试制剂多西他赛注射用浓缩液(自乳化型)和参比制剂多西他赛注射液(商品名:泰索帝®)在诊断为恶性肿瘤且准备接受多西他赛化疗方案患者中的安全性
[Translation] Main purpose: To use docetaxel injection concentrate (self-emulsifying type) (specification: 1mL: 20mg) developed and produced by Beijing Deli Yingjie Pharmaceutical Technology Co., Ltd. as the test preparation, and docetaxel injection (specification: 0.5mL: 20mg, Taxotere®) produced by Sanofi-Aventis Deutschland GmbH as the reference preparation, and conduct an in vivo pharmacokinetic comparison study in accordance with the relevant provisions of the bioequivalence test to investigate the pharmacokinetic behavior of docetaxel in patients diagnosed with malignant tumors and ready to receive docetaxel chemotherapy, and evaluate the bioequivalence of the two preparations.
Secondary purpose: To study the safety of the test preparation docetaxel injection concentrate (self-emulsifying type) and the reference preparation docetaxel injection (trade name: Taxotere®) in patients diagnosed with malignant tumors and ready to receive docetaxel chemotherapy
[Translation] Comparative study on the pharmacokinetics of celecoxib tablets (Ⅰ) in human subjects
主要目的:本研究采用随机开放、四序列、四周期、空腹及餐后给药设计比较空腹及餐后条件下北京德立赛纳医药科技有限公司研制、安徽四环科宝制药有限公司生产的塞来昔布片(I)(70 mg/片)2片与Pfizer Pharmaceuticals LLC生产的塞来昔布胶囊(200 mg/粒,西乐葆®)1粒在健康受试者体内暴露量的差异。并分别评价空腹/餐后条件下塞来昔布片(I)与塞来昔布胶囊的食物效应。
次要目的:为观察健康志愿者单次口服试验药物和对照药物的安全性。
[Translation] Primary Objective: This study used a randomized, open-label, four-sequence, four-period, fasting and fed dosing design to compare the exposure of two celecoxib tablets (I) (70 mg/tablet), developed by Beijing Delishena Pharmaceutical Technology Co., Ltd. and manufactured by Anhui Sihuan Kebao Pharmaceutical Co., Ltd., to one celecoxib capsule (200 mg/capsule, Celebrex®), manufactured by Pfizer Pharmaceuticals LLC, under fasting and fed conditions in healthy volunteers. The food effect of celecoxib tablets (I) and celecoxib capsules was also evaluated under fasting and fed conditions.
Secondary Objective: To observe the safety of a single oral dose of the test drug and the control drug in healthy volunteers.
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