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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date29 Dec 1999 |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.Japan |
First Approval Date29 Mar 1988 |
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MechanismTop II inhibitors |
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Inactive Indication- |
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date19 Dec 1979 |
以安慰剂为对照、评估贝前列素钠缓释片用于特发性肺动脉高压(IPAH)、遗传性肺动脉高压(HPAH)、结缔组织病相关肺动脉高压(CTD-PAH)患者疗效与安全性的上市后临床试验
[Translation] A post-marketing clinical trial to evaluate the efficacy and safety of beraprost sodium extended-release tablets in patients with idiopathic pulmonary arterial hypertension (IPAH), hereditary pulmonary arterial hypertension (HPAH), and connective tissue disease-related pulmonary arterial hypertension (CTD-PAH) using placebo as control
主要目的:以安慰剂为对照,分析治疗开始后16周与基线比较,6分钟步行距离(6MWD)的变化情况,评价贝前列素钠缓释片治疗WHO心功能分级Ⅰ-Ⅲ级的IPAH、HPAH以及CTD-PAH患者的有效性。
[Translation] Main objective: Using placebo as control, analyze the changes in 6-minute walk distance (6MWD) 16 weeks after the start of treatment compared with baseline, and evaluate the effectiveness of beraprost sodium sustained-release tablets in the treatment of IPAH, HPAH and CTD-PAH patients with WHO cardiac function grade Ⅰ-Ⅲ.
贝沙罗汀胶囊单药治疗既往接受至少一次全身治疗的复发或难治性皮肤T细胞淋巴瘤的开放、单臂、多中心临床试验
[Translation] An open, single-arm, multicenter clinical trial of bexarotene capsules as a monotherapy for relapsed or refractory cutaneous T-cell lymphoma who have received at least one previous systemic therapy
主要目的:在皮肤T细胞淋巴瘤(CTCL)中国人群中评价贝沙罗汀胶囊单药治疗既往接受至少一次全身治疗的复发或难治性皮肤T细胞淋巴瘤患者的有效性和安全性。
次要目的:在CTCL中国人群中进行贝沙罗汀胶囊300mg/m2/d的药代动力学研究。
[Translation] Primary objective: To evaluate the efficacy and safety of bexarotene capsules as a monotherapy in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) who have received at least one previous systemic therapy in the Chinese population with cutaneous T-cell lymphoma (CTCL).
Secondary objective: To conduct a pharmacokinetic study of bexarotene capsules 300 mg/m2/d in the Chinese population with CTCL.
/ CompletedNot Applicable [Translation] Bioequivalence study of mirabegron sustained-release tablets in humans under fed conditions
主要研究目的
本研究考察餐后条件下,单次口服深圳万乐药业有限公司研制的米拉贝隆缓释片(受试制剂,规格:25mg/片)与Avara Pharmaceutical Technologies,Inc.生产的米拉贝隆缓释片(参比制剂,规格:25mg/片,商品名:Betmiga®/貝坦利®)的药动学特征,评价两制剂间的生物等效性。
次要研究目的
评价单次口服25mg的米拉贝隆缓释片受试制剂和参比制剂(商品名:Betmiga®/貝坦利®)在健康受试者中的安全性。
[Translation] Main research purpose
This study examines the single oral administration of mirabegron sustained-release tablets (test preparation, specification: 25 mg/tablet) developed by Shenzhen Wanle Pharmaceutical Co., Ltd. and mirabeg produced by Avara Pharmaceutical Technologies, Inc. under postprandial conditions. The pharmacokinetic characteristics of Longon sustained-release tablets (reference preparation, specification: 25mg/tablet, trade name: Betmiga®/Betanil®) were evaluated to evaluate the bioequivalence between the two preparations.
Secondary research purpose
To evaluate the safety of the test preparation and reference preparation (trade name: Betmiga®/Betanil®) of a single oral administration of 25 mg mirabegron extended-release tablets in healthy subjects.
100 Clinical Results associated with Shenzhen Main Luck Pharmaceuticals, Inc.
0 Patents (Medical) associated with Shenzhen Main Luck Pharmaceuticals, Inc.
Promotion in protein a chromatography of WLB303 monoclonal antibody by using dual flowrate to load sample
Author: Yu, Yu-gen ; Deng, Yi-xi ; Luo, Hao-hui ; Li, Le ; Meng, Guo-ji
With the advances in cell culture expression levels and production capacity in the last two decades, it is crucial to improve the binding capacity of protein A resin and decrease processing time.Then the dual flowrate loading strategy is proposed.A cubic equation of GE MabSelect dynamic binding capacity (DBC) was created by measuring several DBC values of the retention time with WLB303 mAb.A unique DBC table of GE MabSelect was generated subsequently to design dual flow rate loading strategy.The fastest dual flowrate loading mode was firstly confirmed by using purified WLB303 mAb to practice on a 2.7 mL column.And it was demonstrated to show obvious promotion in process efficiency by using clarified harvest to practice on a 7 mL column.
100 Deals associated with Shenzhen Main Luck Pharmaceuticals, Inc.
100 Translational Medicine associated with Shenzhen Main Luck Pharmaceuticals, Inc.