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Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
First Approval Date- |
评价邦瑞替尼片对照最佳可用疗法治疗羟基脲耐药或不耐受的真性红细胞增多症的有效性和安全性的开放、随机对照、多中心Ⅲ期临床研究(BEWELL-302研究)
[Translation] An open, randomized, controlled, multicenter Phase III clinical study to evaluate the efficacy and safety of Bonretinib tablets compared with the best available therapy in the treatment of polycythemia vera that is resistant or intolerant to hydroxyurea (BEWELL-302 study)
主要目的:
评价邦瑞替尼片治疗HU耐药/不耐受的PV受试者的有效性。
次要目的:
评价邦瑞替尼片治疗HU耐药/不耐受的PV受试者有效率的持续性;
评价邦瑞替尼片治疗HU耐药/不耐受的PV受试者的安全性。
[Translation] Primary purpose:
To evaluate the efficacy of Bonretinib tablets in the treatment of PV subjects with HU resistance/intolerance.
Secondary purpose:
To evaluate the sustainability of the efficacy of Bonretinib tablets in the treatment of PV subjects with HU resistance/intolerance;
To evaluate the safety of Bonretinib tablets in the treatment of PV subjects with HU resistance/intolerance.
邦瑞替尼片在健康受试者中随机、开放、单剂量、交叉的相对生物利用度及食物影响的Ⅰ期临床研究
[Translation] A randomized, open-label, single-dose, crossover phase I clinical study on the relative bioavailability and food effect of bonevitinib tablets in healthy subjects
主要研究目的: 比较空腹状态下单次口服杭州邦顺制药有限公司的受试制剂邦瑞替尼片(1片,规格:16mg)与参比制剂邦瑞替尼片(1片,规格:16mg)在健康成年受试者体内的相对生物利用度,评价两种制剂的生物等效性。 评价食物对邦瑞替尼片(1片/次,规格:16mg)在健康受试者体内药代动力学特征的影响。
次要研究目的: 观察空腹/餐后状态下单次口服邦瑞替尼片(规格:16mg)在健康受试者中的安全性。
[Translation] Main study objectives: To compare the relative bioavailability of the test preparation Bangretinib tablets (1 tablet, specification: 16 mg) and the reference preparation Bangretinib tablets (1 tablet, specification: 16 mg) of Hangzhou Bangshun Pharmaceutical Co., Ltd. in healthy adult subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations. To evaluate the effect of food on the pharmacokinetic characteristics of Bangretinib tablets (1 tablet/time, specification: 16 mg) in healthy subjects.
Secondary study objectives: To observe the safety of a single oral administration of Bangretinib tablets (specification: 16 mg) in healthy subjects under fasting/postprandial conditions.
评价OB756片治疗芦可替尼不耐受的中高危骨髓纤维化患者的安全性和有效性开放、单臂、多中心Ⅱb期临床研究(BEWELL-201研究)
[Translation] An open, single-arm, multicenter Phase IIb clinical study to evaluate the safety and efficacy of OB756 tablets in the treatment of intermediate- and high-risk myelofibrosis patients who are intolerant to ruxolitinib (BEWELL-201 study)
主要目的:
评价OB756片治疗芦可替尼不耐受的中高危骨髓纤维化(MF)受试者的脾脏体积缩小有效率。
次要目的:
评价OB756片治疗芦可替尼不耐受的中高危骨髓纤维化(MF)受试者的客观有效率、脾响应、MF相关症状改善等;
评价OB756片治疗芦可替尼不耐受的中高危骨髓纤维化(MF)受试者的安全性。
[Translation] Primary purpose:
To evaluate the effectiveness of OB756 tablets in reducing spleen volume in subjects with intermediate- and high-risk myelofibrosis (MF) who are intolerant to ruxolitinib.
Secondary purpose:
To evaluate the objective effectiveness rate, spleen response, and improvement of MF-related symptoms in subjects with intermediate- and high-risk myelofibrosis (MF) who are intolerant to ruxolitinib;
To evaluate the safety of OB756 tablets in the treatment of subjects with intermediate- and high-risk myelofibrosis (MF) who are intolerant to ruxolitinib.
100 Clinical Results associated with Hangzhou Guangliang Biomedical Co., Ltd.
0 Patents (Medical) associated with Hangzhou Guangliang Biomedical Co., Ltd.
100 Deals associated with Hangzhou Guangliang Biomedical Co., Ltd.
100 Translational Medicine associated with Hangzhou Guangliang Biomedical Co., Ltd.