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Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date15 May 2009 |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date20 Mar 2008 |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.US |
First Approval Date28 Dec 2004 |
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] A randomized, double-blind phase II clinical trial of Smilax glabra total glycosides tablets in the treatment of rheumatoid arthritis (dampness-induced arthritis 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] Using ACR20 as the primary efficacy indicator, a randomized, double-blind, placebo-controlled, multicenter, dose-finding trial design was adopted to preliminarily evaluate the efficacy and safety of different doses of Smilax glabra total glycosides tablets in the treatment of rheumatoid arthritis (dampness obstruction syndrome) and to explore the optimal 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 cancer, hepatocellular carcinoma, 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 profile and efficacy of AL3810 in patients with locally advanced or metastatic gastric cancer, hepatocellular carcinoma, or nasopharyngeal carcinoma. To determine the pharmacokinetic (PK) profile of AL3810 and its potential metabolites after oral administration in patients with locally advanced or metastatic gastric cancer, hepatocellular carcinoma, or nasopharyngeal carcinoma. To determine the pharmacodynamic (PD) profile of AL3810. Optional: Pharmacogenomic (PG) analysis of interpatient differences in protein-coding genes involved in absorption/distribution/metabolism/excretion (ADME)
/ CompletedNot Applicable [Translation] Study plan for bioequivalence study of lacosamide tablets in humans
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] The pharmacokinetic parameters and relative bioavailability of lacosamide tablets (specification: 100 mg) developed by Jiangxi Qingfeng Pharmaceutical Co., Ltd. and lacosamide tablets (trade name: VIMPAT; specifications: 100 mg, 200 mg) produced by the original research company UCB were investigated, and whether the two were bioequivalent when administered on an empty stomach or after a meal in healthy subjects was evaluated.
100 Clinical Results associated with Hangzhou Rongli Pharmaceutical Technology Co., Ltd.
0 Patents (Medical) associated with Hangzhou Rongli Pharmaceutical Technology Co., Ltd.
100 Deals associated with Hangzhou Rongli Pharmaceutical Technology Co., Ltd.
100 Translational Medicine associated with Hangzhou Rongli Pharmaceutical Technology Co., Ltd.