按有关生物等效性试验的规定，选择Pharmacia and Upjohn Co LLC为持证商的氨氯地平阿托伐他汀钙片（商品名：Caduet®，规格：5mg/10mg（以氨氯地平/阿托伐他汀计））为参比制剂，对翎耀生物科技（上海）有限公司提供的受试制剂氨氯地平阿托伐他汀钙片（规格：5mg/10mg（以氨氯地平/阿托伐他汀计））进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。

开始日期2024-05-20

申办/合作机构

翎耀生物科技（上海）有限公司

CTR20233897 / CompletedN/A

氨氯地平阿托伐他汀钙片在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、三序列、三周期、部分重复交叉生物等效性试验

主要研究目的：按有关生物等效性试验的规定，选择Pharmacia and Upjohn Co LLC为持证商的氨氯地平阿托伐他汀钙片（商品名：Caduet®，规格：5mg/10mg（以氨氯地平/阿托伐他汀计））为参比制剂，对宁波大红鹰药业股份有限公司提供的受试制剂氨氯地平阿托伐他汀钙片（规格：5mg/10mg（以氨氯地平/阿托伐他汀计））进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂氨氯地平阿托伐他汀钙片（规格：5mg/10mg（以氨氯地平/阿托伐他汀计））和参比制剂氨氯地平阿托伐他汀钙片（商品名：Caduet®，规格：5mg/10mg（以氨氯地平/阿托伐他汀计））的安全性。

开始日期2023-12-22

申办/合作机构

宁波大红鹰药业股份有限公司

CTR20231343 / CompletedN/A

氨氯地平阿托伐他汀钙片单中心、随机、开放、单剂量、两制剂、三周期、部分重复交叉健康人体餐后条件下生物等效性试验

主要研究目的观察中国健康受试者餐后条件下口服受试制剂氨氯地平阿托伐他汀钙片（规格：5mg /10mg，北京双鹭药业股份有限公司生产）与参比制剂氨氯地平阿托伐他汀钙片（商品名：多达一®，规格：5mg /10mg；Pfizer Manufacturing Deutschland GmbH(Betriebsstatte Freibrug)生产）的药代动力学特点，评价两制剂的人体生物等效性。次要研究目的观察受试制剂氨氯地平阿托伐他汀钙片和参比制剂多达一®在健康成年受试者中的安全性。

开始日期2023-07-06

申办/合作机构

北京双鹭药业股份有限公司

100 项与 HMG-CoA reductase x VDCCs 相关的临床结果

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100 项与 HMG-CoA reductase x VDCCs 相关的转化医学

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0 项与 HMG-CoA reductase x VDCCs 相关的专利（医药）

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项与 HMG-CoA reductase x VDCCs 相关的文献（医药）

2002-06-01·Journal of Hypertension2区 · 医学

A gene expression analysis in rat kidney following high and low salt intake

2区 · 医学

Article

作者: Dechend, Ralf ; Luft, Friedrich C. ; Gorzelniak, Kerstin ; Maass, Philipp G. ; Monti, Jan ; Sharma, Arya M. ; Barta, Peter ; Hubner, Norbert ; Muller, Dominik N.

BACKGROUNDThe effects of salt intake on renal regulation have been investigated for decades. To find new pathways and to demonstrate the utility of oligonucleotide expression arrays, we studied whole kidneys.METHODSEight Sprague-Dawley rats were divided into two groups. One group received a 6% salt (by weight) diet, while the other group received a 0.3%, otherwise identical, salt diet for 7 days. The rats were sacrificed after 7 days and the left kidney was subjected to RNA extraction. Oligonucleotide expression arrays (Affymetrix) were used to determine downregulation and upregulation, comparing high with low salt intake. Four rats from each group were studied separately.RESULTSThe experiments were reproducible. Thirty genes were downregulated with the high-salt diet, while 35 genes were upregulated. The renin gene, beta-2 glycoprotein-1, retinol binding protein, annexin VI, and the PTP2C protein tyrosine phosphatase were among the downregulated genes. The angiotensin II receptor type 1B receptor, HMG-CoA reductase, B7 antigen, and the rat calcium channel beta subunit III were among the upregulated genes. Differentially regulated were the p55 subunit (upregulated) and the p50 subunit (downregulated) of the phosphatidyl inositol 3-kinase enzyme complex. We verified our results by selecting a high-salt downregulated gene (renin) and an upregulated gene (B7 antigen) and subjecting these genes to real-time polymerase chain reaction. The results were consistent.CONCLUSIONOligonucleotide expression arrays can detect novel genes encoding for proteins not generally associated with responses to varied salt intake. Experiments of this nature have substantial limitations and require detailed verification. However, overall, the utility is promising.

Journal of Clinical Medicine3区 · 医学

Statin-Related Myotoxicity: A Comprehensive Review of Pharmacokinetic, Pharmacogenomic and Muscle Components

3区 · 医学

ReviewOA

作者: Pirmohamed, Munir ; Turner, Richard Myles

Statins are a cornerstone in the pharmacological prevention of cardiovascular disease. Although generally well tolerated, a small subset of patients experience statin-related myotoxicity (SRM). SRM is heterogeneous in presentation; phenotypes include the relatively more common myalgias, infrequent myopathies, and rare rhabdomyolysis. Very rarely, statins induce an anti-HMGCR positive immune-mediated necrotizing myopathy. Diagnosing SRM in clinical practice can be challenging, particularly for mild SRM that is frequently due to alternative aetiologies and the nocebo effect. Nevertheless, SRM can directly harm patients and lead to statin discontinuation/non-adherence, which increases the risk of cardiovascular events. Several factors increase systemic statin exposure and predispose to SRM, including advanced age, concomitant medications, and the nonsynonymous variant, rs4149056, in SLCO1B1, which encodes the hepatic sinusoidal transporter, OATP1B1. Increased exposure of skeletal muscle to statins increases the risk of mitochondrial dysfunction, calcium signalling disruption, reduced prenylation, atrogin-1 mediated atrophy and pro-apoptotic signalling. Rare variants in several metabolic myopathy genes including CACNA1S, CPT2, LPIN1, PYGM and RYR1 increase myopathy/rhabdomyolysis risk following statin exposure. The immune system is implicated in both conventional statin intolerance/myotoxicity via LILRB5 rs12975366, and a strong association exists between HLA-DRB1*11:01 and anti-HMGCR positive myopathy. Epigenetic factors (miR-499-5p, miR-145) have also been implicated in statin myotoxicity. SRM remains a challenge to the safe and effective use of statins, although consensus strategies to manage SRM have been proposed. Further research is required, including stringent phenotyping of mild SRM through N-of-1 trials coupled to systems pharmacology omics- approaches to identify novel risk factors and provide mechanistic insight.

项与 HMG-CoA reductase x VDCCs 相关的新闻（医药）

2023-05-28

·医药地理

2022年获批进口药品分析（心血管系统用药、神经系统用药）

本文数据来自于CPM新药研发监测数据库（cpm.pharmadl.com）。心血管系统用药2022年NMPA批准的进口心血管系统用药，共计71个（按照注册证号分类），获批品种数量前五的几家企业分别为拜耳（12个）、赛诺菲（8个）、勃林格殷格翰（7个）、Kyowa Kirin（6个）、Organon Pharma（6个）；涉及靶点排名前三的是AGTR1（20个）、CACNA1C（14个）、Hmgcr（14个）。在政策相关度方面，2022年获批的进口心血管系统用药中，2022国家医保目录品种共有67个，没有带量采购招标品种。神经系统用药2022年NMPA批准的进口神经系统用药，共计55个（按照注册证号分类），获批品种前三的企业分别是Napp Pharmaceuticals（8个）、Dr Reddy's Laboratories（6个）、Mundipharma Research（6个）；涉及靶点排名前三的是Nav1.1（9个）、ACHE（7个）、OPRK1（6个）。在政策相关度方面，2022年获批的进口神经系统用药中，2022国家医保目录品种共有49个，没有带量采购招标品种。年度发布2023年《全球药研新动态》《中国医院市场用药格局》（2023版）2023年《数图药讯》权威发布2021年度中国医药工业百强榜单解读中国仿制药发展报告（2022版）医药行业专项报告中国医药中间体和原料药行业调研报告中国非甾体抗炎类原料药市场调研报告中国祛痰类原料药市场调研报告中国钙拮抗剂类原料药市场调研报告中国血管紧张素Ⅱ受体拮抗剂类原料药市场调研报告中国口服血糖调节类原料药市场调研报告中国中枢兴奋类原料药市场调研报告中国抗痛风类原料药市场调研报告中国脑血管病类原料药市场调研报告END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

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