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Mechanism5-HT1A receptor agonists [+2] |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date10 Jul 2015 |
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Mechanism- |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ CompletedNot Applicable [Translation] Bioequivalence study of utpatinib extended-release tablets
主要目的
比较空腹和餐后给药条件下,山东朗诺制药有限公司提供的乌帕替尼缓释片(15mg(按C17H19F3N6O计))与AbbVie Deutschland GmbH & Co. KG持证的乌帕替尼缓释片(按C17H19F3N6O计15mg,商品名:瑞福/RINVOQ)在健康成年人群中吸收程度和速度的差异,评价其生物等效性。
次要目的
评价空腹和餐后给药条件下,山东朗诺制药有限公司提供的乌帕替尼缓释片(15mg(按C17H19F3N6O计))与AbbVie Deutschland GmbH & Co. KG持证的乌帕替尼缓释片(按C17H19F3N6O计15mg,商品名:瑞福/RINVOQ)在健康成年人群中的安全性。
[Translation] Primary Objective To compare the absorption rate and extent of utpatinib extended-release tablets (15 mg (C17H19F3N6O)) supplied by Shandong Langnuo Pharmaceutical Co., Ltd. with those of utpatinib extended-release tablets (15 mg (C17H19F3N6O) certified by AbbVie Deutschland GmbH & Co. KG, trade name: RINVOQ) in healthy adults under fasting and postprandial administration conditions, and to evaluate their bioequivalence.
Secondary Objective To evaluate the safety of utpatinib extended-release tablets (15 mg (C17H19F3N6O)) supplied by Shandong Langnuo Pharmaceutical Co., Ltd. with those of utpatinib extended-release tablets (15 mg (C17H19F3N6O) certified by AbbVie Deutschland GmbH & Co. KG, trade name: RINVOQ) in healthy adults under fasting and postprandial administration conditions.
/ CompletedNot Applicable BR170720口服混悬液在健康受试者中的生物等效性试验
[Translation] Bioequivalence study of BR170720 oral suspension in healthy volunteers
主要目的:以山东百诺医药股份有限公司研制的BR170720口服混悬液(规格:30 ml:30 mg)为受试制剂(T),Otsuka Pharmaceutical Co Ltd.持证生产的布瑞哌唑片(商品名:Rexulti®,规格:2 mg)为参比制剂(R),考察受试制剂和参比制剂在空腹或餐后条件下单次给药的药代动力学参数,评价两制剂是否具有生物等效性。
次要目的:评价受试制剂T(BR170720口服混悬液,规格:30 ml:30 mg,山东百诺医药股份有限公司研制)与参比制剂R(布瑞哌唑片,商品名:Rexulti®,规格:2 mg,Otsuka Pharmaceutical Co Ltd.持证生产)在健康受试者中的安全性。
[Translation] Primary Objective: Using BR170720 oral suspension (30 ml, 30 mg) developed by Shandong Biono Pharmaceutical Co., Ltd. as the test formulation (T) and brexpiprazole tablets (trade name: Rexulti®, 2 mg) manufactured by Otsuka Pharmaceutical Co., Ltd. as the reference formulation (R), we investigated the pharmacokinetic parameters of the test and reference formulations after single administration under fasting and fed conditions and evaluated their bioequivalence.
Secondary Objective: To evaluate the safety of test formulation T (BR170720 oral suspension, 30 ml, 30 mg, developed by Shandong Biono Pharmaceutical Co., Ltd.) and reference formulation R (brexpiprazole tablets, trade name: Rexulti®, 2 mg, manufactured by Otsuka Pharmaceutical Co., Ltd.) in healthy volunteers.
/ RecruitingNot Applicable 健康参与者在空腹及餐后状态下单次口服吡仑帕奈细粒剂的人体生物等效性试验
[Translation] A bioequivalence study of perampanel fine granules in healthy participants after single oral administration in fasting and fed states
主要目的:
以山东朗诺制药有限公司生产的吡仑帕奈细粒剂为受试制剂(T),以エーザイ株式会社持证并生产的吡仑帕奈细粒剂(商品名:Fycompa®)为参比制剂(R),评估健康参与者在空腹及餐后状态下单次口服受试制剂和参比制剂的药代动力学特征,评价两种制剂的人体生物等效性。
次要目的:
考察健康参与者口服受试制剂和参比制剂后的安全性。
评价吡仑帕奈细粒剂在中国健康参与者中的适口性,为吡仑帕奈细粒剂用药口感提供依据。
[Translation] Primary Objective:
Using perampanel fine granules produced by Shandong Langnuo Pharmaceutical Co., Ltd. as the test formulation (T), and perampanel fine granules (trade name: Fycompa®) licensed and produced by Aerosei Co., Ltd. as the reference formulation (R), the pharmacokinetic characteristics of the test and reference formulations after single oral administration in healthy volunteers under fasting and fed conditions were evaluated, and the bioequivalence of the two formulations was assessed.
Secondary Objective:
Investigate the safety of the test and reference formulations after oral administration in healthy volunteers.
Evaluate the palatability of perampanel fine granules in healthy Chinese volunteers to provide a basis for the oral palatability of perampanel fine granules.
100 Clinical Results associated with Shandong Langnuo Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Shandong Langnuo Pharmaceutical Co. Ltd.
100 Deals associated with Shandong Langnuo Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Shandong Langnuo Pharmaceutical Co. Ltd.