苹果酸舒尼替尼胶囊在健康受试者中随机、开放、两制剂、两序列、两周期、双交叉、空腹和餐后状态下的生物等效性试验
[Translation] Bioequivalence study of sunitinib malate capsules in healthy subjects under randomized, open-label, two-dose, two-sequence, two-period, double-crossover, fasting and fed states
1)不能手术的晚期肾细胞癌(RCC);2)甲磺酸伊马替尼治疗失败或不能耐受的胃肠间质瘤(GIST);3)不可切除的,转移性高分化进展期胰腺神经内分泌瘤(pNET)成年患者。
[Translation] 1) Inoperable advanced renal cell carcinoma (RCC); 2) Gastrointestinal stromal tumor (GIST) that fails or cannot be tolerated with imatinib mesylate; 3) Unresectable, metastatic well-differentiated advanced stage Adult patients with pancreatic neuroendocrine tumor (pNET).
甲磺酸伊马替尼片在健康受试者中随机、开放、两制剂、单次给药、两周期、两序列餐后状态下的生物等效性试验
[Translation] Bioequivalence trial of imatinib mesylate tablets in healthy subjects in a randomized, open-label, two-dose, single-dose, two-cycle, two-sequence postprandial state
主要目的:考察广州科锐特生物科技有限公司研制的受试制剂甲磺酸伊马替尼片(100mg)与Novartis Pharma Stein AG生产的参比制剂(格列卫®100mg)的相关药代动力学参数及相对生物利用度,评价两制剂的生物等效性,为广州科锐特生物科技有限公司研制的甲磺酸伊马替尼片的临床应用提供依据。
次要目的:观察两制剂在餐后条件下健康受试者中的安全性。
[Translation] Main purpose: To investigate the related pharmacokinetics of the test preparation imatinib mesylate tablets (100mg) developed by Guangzhou Crete Biotechnology Co., Ltd. and the reference preparation (Gleevec® 100mg) produced by Novartis Pharma Stein AG The biological parameters and relative bioavailability of the two preparations were evaluated, and the bioequivalence of the two preparations was evaluated, which provided the basis for the clinical application of imatinib mesylate tablets developed by Guangzhou Career Biotechnology Co., Ltd.
Secondary objective: To observe the safety of both formulations in healthy subjects under postprandial conditions.
盐酸厄洛替尼片(150mg)在健康受试者中随机、开放、两制剂、单次给药、两周期、两序列空腹状态下的生物等效性试验
[Translation] Randomized, open-label, two-dose, single-dose, two-cycle, two-sequence fasting bioequivalence trial of erlotinib hydrochloride tablets (150 mg) in healthy subjects
主要目的以广州科锐特生物科技有限公司生产的盐酸厄洛替尼片为受试制剂(T制剂),瑞士罗氏制药生产的盐酸厄洛替尼片(商品名:Tarceva®)为参比制剂(R制剂),评价二者单次空腹给药的生物等效性。次要研究目的观察两制剂在健康受试者中的安全性。
[Translation] The main purpose is to take erlotinib hydrochloride tablets produced by Guangzhou Crete Biotechnology Co., Ltd. as the test preparation (T preparation), and erlotinib hydrochloride tablets (trade name: Tarceva®) produced by Swiss Roche Pharmaceuticals as the reference preparation (R formulation), to evaluate the bioequivalence of the two in a single fasting administration. Secondary study objectives To observe the safety of both formulations in healthy subjects.
100 Clinical Results associated with Guangzhou Keruite Biotechnology Co., Ltd
0 Patents (Medical) associated with Guangzhou Keruite Biotechnology Co., Ltd
100 Deals associated with Guangzhou Keruite Biotechnology Co., Ltd
100 Translational Medicine associated with Guangzhou Keruite Biotechnology Co., Ltd