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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 |
[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.
/ Not yet recruitingPhase 1 [Translation] Comparative study on the pharmacokinetics of celecoxib tablets (Ⅰ) in humans
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)(60 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] Main purpose: This study used a randomized open, four-sequence, four-period, fasting and postprandial dosing design to compare the differences in exposure of 2 tablets of celecoxib tablets (I) (60 mg/tablet) developed by Beijing Delishena Pharmaceutical Technology Co., Ltd. and produced by Anhui Sihuan Kebao Pharmaceutical Co., Ltd. and 1 tablet of celecoxib capsules (200 mg/capsule, Celebrex®) produced by Pfizer Pharmaceuticals LLC in healthy subjects under fasting and postprandial conditions. The food effects of celecoxib tablets (I) and celecoxib capsules under fasting/postprandial conditions were evaluated respectively.
Secondary purpose: To observe the safety of single oral administration of test drugs and control drugs in healthy volunteers.
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