更新于：2024-11-04
Cinitapride Tartrate
酒石酸西尼必利
更新于：2024-11-04
概要
基本信息
药物类型 小分子化药 |
别名 4-Amino-N-(1-(3-cyclohexen-1-ylmethyl)-4-piperidyl)-2-ethoxy-5-nitrobenzamide、Cidine、Cinigest + [8] |
作用机制 5-HT1A receptor激动剂(5-羟色胺1A受体激动剂)、5-HT1B receptor激动剂(5-羟色胺1B受体激动剂)、5-HT1D receptor激动剂(5-羟色胺1D受体激动剂) |
非在研适应症- |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
结构
分子式C25H36N4O10 |
InChIKeyHVANMRCHFMTSEG-LREBCSMRSA-N |
CAS号96623-56-2 |
关联
5
项与 酒石酸西尼必利 相关的临床试验浙江远力健药业有限责任公司研制的酒石酸西尼必利片（规格：1 mg）与持证商为Almirall, S.A.的酒石酸西尼必利片（商品名：希笛尼®/Cidine®，规格：1 mg）在中国健康受试者中进行的单中心、随机、开放、两制剂、单次给药、两周期、两序列、双交叉设计的空腹生物等效性研究，以及在中国健康受试者中进行的单中心、随机、开放、两制剂、单次给药、四周期、两序列、完全重复交叉设计的餐后生物等效性研究
A Randomized, Double-blind, Double-dummy, Active Drug Parallel Controlled, Multi-center Clinical Trial on the Efficacy and Safety of Cinitapride Tablets in the Treatment of Mild to Moderate Functional Dyspepsia
酒石酸西尼必利片人体生物等效性研究
100 项与 酒石酸西尼必利 相关的临床结果
登录后查看更多信息
100 项与 酒石酸西尼必利 相关的转化医学
登录后查看更多信息
100 项与 酒石酸西尼必利 相关的专利（医药）
登录后查看更多信息
54
项与 酒石酸西尼必利 相关的文献（医药）2023-10-31BMC gastroenterology
Prokinetics for the treatment of functional dyspepsia: an updated systematic review and network meta-analysis.
Review
作者: Li, Yanqing ; Liu, Han ; Wang, Nana ; Qi, Qingqing
BACKGROUND:
Since the previous network meta-analysis assessing the efficacy of prokinetics for functional dyspepsia (FD), there have been a number of new studies and cinitapride is a new prokinetic agent for FD. This updated meta-analysis aimed to explore the efficacy and safety of prokinetics for FD.
METHODS:
An updated study search in Pubmed, EMBASE, Cochrane Library and Web of Science was conducted in literatures published from July 2015 to March 2023. Randomized controlled trials investigating the use of prokinetics in adult FD patients were included. The primary outcome was the total efficacy rate and the secondary outcome was adverse events. A Bayesian network meta-analysis was performed using R software.
RESULTS:
A total of 28 studies were included. Network meta-analysis showed that metoclopramide had a higher total efficacy rate than mosapride (OR: 3.53, 95%CI: 1.70-7.47), domperidone (OR: 2.29, 95%CI: 1.16-4.63), itopride(OR: 2.77, 95%CI: 1.41-5.59), acotiamide(OR: 2.63, OR: 1.33-5.36), and placebo(OR: 5.68, 95%CI: 2.98-11.10), however similar to cinitapride (OR: 1.62, 95%CI: 0.75-3.53). Cinitapride had a higher total efficacy rate than mosapride (OR: 2.18, 95%CI: 1.16-4.14) and placebo (OR: 3.52, 95%CI: 2.01-6.24). Cinitapride had lower risk of total adverse events than domperidone. There was no difference in the risk of drug-related adverse events between the prokinetics.
CONCLUSIONS:
Metoclopramide and cinitapride may have a better efficacy than other prokinetics in the treatment of FD, and cinitapride may have a lower risk of total adverse events. Further studies using uniform definitions or validated tools to measure the total efficacy rate are needed.
2023-01-01Caspian journal of internal medicine
Efficacy of prokinetic agents in diabetic gastroparesis comparing symptomatology and scintigraphy - An open-label trial.
Article
作者: Pratti, Madhuri ; Dhingra, Vandana ; Khapre, Meenakshi ; Kant, Ravi ; Yadav, Poonam
Background:
It is pertinent to objectively assess the severity of diabetic gastroparesis and tailor treatment accordingly. The current study was planned to document gastroparesis by gastric emptying scintigraphy (GES) objectively and see the effect of medications and diet control on clinical and GES after four weeks.
Methods:
A prospective, open-label randomized trial was conducted in the Department of Internal Medicine at a tertiary care teaching hospital over twelve months. Type 2 diabetic patients aged 18-65 years diagnosed with a case of delayed gastric emptying by gastric scintigraphy were included. All baseline GSCI was recorded, and then they were allotted to 3 groups - Group-1 (Levosulpiride 25mg once daily), group-2 (Cinitapride 1mg thrice daily), and Group-3 (Waitlisted control) by block randomization and followed-up weekly till four weeks. After four weeks duration, if not improved clinically, then Group-3 on diet and diabetic control only, were randomized into Levosulpiride 25mg once daily (Group 1), and Cinitapride 1mg Thrice daily (Group 2) for the next four weeks.
Results:
Forty confirmed cases with diabetic gastroparesis documented by Gastroparesis Symptom Cardinal Index (GCSI) scoring and later by Scintigraphy (GES) were included in this study. However, there was no statistically significant difference between the Levosulpiride and Cinitapride groups when all symptoms were taken into account. Levosulpiride was significantly more effective than Cinitapride in improving individual symptoms like nausea, vomiting, stomach fullness, and early satiety.
Conclusion:
Levosulpiride is better than Cinitapride in improving the symptoms of diabetic gastroparesis but no significant effect on gastric scintigraphy.
2022-11-01Clinical and translational science
Article
作者: Casajús, Ana ; Campodónico, Diana María ; Parra‐Garcés, Raúl ; Soria‐Chacartegui, Paula ; Mejía‐Abril, Gina ; Román, Manuel ; Navares‐Gómez, Marcos ; Martín‐Vílchez, Samuel ; Zubiaur, Pablo ; Ochoa, Dolores ; Villapalos‐García, Gonzalo ; Abad‐Santos, Francisco ; Gómez‐Fernández, Antía
Abstract:
Cinitapride is a gastrointestinal prokinetic drug, prescribed for the treatment of functional dyspepsia, and as an adjuvant therapy for gastroesophageal reflux disease. In this study, we aimed to explore the impact of relevant variants in CYP3A4 and CYP2C8 and other pharmacogenes, along with demographic characteristics, on cinitapride pharmacokinetics and safety; and to evaluate the impact of CYP2C8 alleles on the enzyme's function. Twenty‐five healthy volunteers participating in a bioequivalence clinical trial consented to participate in the study. Participants were genotyped for 56 variants in 19 genes, including cytochrome P450 (CYP) enzymes (e.g., CYP2C8 or CYP3A4) or transporters (e.g., SLC or ABC), among others. CYP2C8*3 carriers showed a reduction in AUC of 42% and Cmax of 35% compared to *1/*1 subjects (p = 0.003 and p = 0.011, respectively). *4 allele carriers showed a 45% increase in AUC and 63% in Cmax compared to *1/*1 subjects, although these differences did not reach statistical significance. CYP2C8*3 and *4 alleles may be used to infer the following pharmacogenetic phenotypes: ultrarapid (UM) (*3/*3), rapid (RM) (*1/*3), normal (NM) (*1/*1), intermediate (IM) (*1/*4), and poor (PM) metabolizers (*4/*4). In this study, we properly characterized RMs, NMs, and IMs; however, additional studies are required to properly characterize UMs and PMs. These findings should be relevant with respect to cinitapride, but also to numerous CYP2C8 substrates such as imatinib, loperamide, montelukast, ibuprofen, paclitaxel, pioglitazone, repaglinide, or rosiglitazone.
100 项与 酒石酸西尼必利 相关的药物交易
登录后查看更多信息
研发状态
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 消化不良 | 西班牙 | 2010-04-16 | |
| 胃食管反流 | 西班牙 | 2010-04-16 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 383 | 淵製壓築獵壓夢醖願壓(鏇鬱範積選壓醖製鹹蓋) = Cinitapride-related adverse events were observed in 9.1% of patients, including 1 patient with extrapyramidal symptoms 鹽衊齋鹽製繭製餘蓋鹽 (齋觸窪醖願積艱艱製淵 ) 更多 | - | 2014-04-01 | |||
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用