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土茯苓总苷片治疗类风湿关节炎(湿邪痹阻证)的随机、双盲Ⅱ期临床试验
[Translation] Randomized, double-blind phase II clinical trial of Tufuling total glycosides tablets in the treatment of rheumatoid arthritis (damp pathogenic obstruction syndrome)
以ACR20为主要疗效指标,采用随机、双盲、安慰剂平行对照、多中心、剂量探索试验设计,初步评价不同剂量土茯苓总苷片治疗类风湿关节炎(湿邪痹阻证)的有效性和安全性,探索最佳有效安全剂量。
[Translation] Taking ACR20 as the main efficacy index, a randomized, double-blind, placebo-controlled, multi-center, dose-exploring trial design was used to preliminarily evaluate the efficacy of different doses of Tuckahoe Total Glycosides Tablets in the treatment of rheumatoid arthritis (dampness pathogenic obstruction syndrome). and safety, to explore the best effective and safe dose.
一项开放性Ib期研究,以确定局部晚期或转移性胃癌、肝细胞癌或鼻咽癌患者口服AL3810的安全性
[Translation] An open-label Phase Ib study to determine the safety of oral AL3810 in patients with locally advanced or metastatic gastric, hepatocellular, or nasopharyngeal carcinoma
评价AL3810治疗局部晚期或转移性胃癌、肝细胞癌或鼻咽癌患者的安全性特征、疗效。确定局部晚期或转移性胃癌、肝细胞癌或鼻咽癌患者经口给药后AL3810及其潜在代谢产物的药代动力学(PK)概况确定AL3810的药效学(PD)概况。可选部分:对参与吸收/分布/代谢/排泄(ADME)的蛋白编码基因的患者间差异开展药物基因组学(PG)分析
[Translation] To evaluate the safety characteristics and efficacy of AL3810 in the treatment of patients with locally advanced or metastatic gastric cancer, hepatocellular carcinoma or nasopharyngeal carcinoma. To determine the pharmacokinetic (PK) profiles of AL3810 and its potential metabolites following oral administration in patients with locally advanced or metastatic gastric, hepatocellular, or nasopharyngeal carcinomas To determine the pharmacodynamic (PD) profiles of AL3810. Optional part: Pharmacogenomics (PG) analysis of interpatient differences in protein-coding genes involved in absorption/distribution/metabolism/excretion (ADME)
[Translation] Study Protocol for Human Bioequivalence Test of Lacosamide Tablets
考察江西青峰药业有限公司研制的拉科酰胺片(规格:100mg)与原研UCB公司生产的拉科酰胺片(商品名:VIMPAT;规格:100mg、200mg)的药代动力学参数及相对生物利用度,评价二者在健康受试者空腹给药状态下或餐后给药状态下是否具有生物等效性。
[Translation] To investigate the pharmacokinetic parameters and relative bioavailability of lacosamide tablets (specification: 100mg) developed by Jiangxi Qingfeng Pharmaceutical Co., Ltd. and lacosamide tablets (trade name: VIMPAT; specifications: 100mg, 200mg) produced by the original research UCB company To evaluate whether the two are bioequivalent in the fasting state or the postprandial state of healthy subjects.
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