[Translation] A single-center, open-label, balanced, randomized, single-dose, two-period, double-crossover pilot study of bioequivalence in healthy volunteers in the fasting and fed states

比较在空腹及餐后给药条件下，海南全星制药有限公司提供的胞磷胆碱钠胶囊（0.2g/粒）与齐鲁制药有限公司生产的胞磷胆碱钠胶囊（0.2g/粒）在健康成年人群中吸收程度和速度的差异，估算其药代动力学参数及个体内变异度，用于计算和调整正式试验样本量，同时验证分析方法、试验流程、采血点和试验设计的合理性。

[Translation]

To compare the differences in absorption extent and rate between Citicoline Sodium Capsules (0.2g/capsule) provided by Hainan Quanxing Pharmaceutical Co., Ltd. and Citicoline Sodium Capsules (0.2g/capsule) produced by Qilu Pharmaceutical Co., Ltd. in healthy adults under fasting and postprandial administration conditions, and to estimate their pharmacokinetic parameters and intra-individual variability for calculation and adjustment of the formal trial sample size, and to verify the rationality of the analytical method, experimental process, blood collection points and experimental design.

Start Date-

Sponsor / Collaborator

Hainan Quanxing Pharmaceutical Co. Ltd.

NCT06522581 / RecruitingPhase 1IIT

Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy

Hypoxic ischemic encephalopathy is an acute or subacute brain injury, due to asphyxia in neonates, leading to mortality and long-term morbidity. Its prevalence varies across regions, with developed countries reporting rates of 1.5 per 1000 live births, while developing nations experience a wider range from 2.3 to 26.5 per 1000 live births.
Infants afflicted with moderate HIE face a 10% risk of mortality, with surviving individuals encountering a 30% chance of developing disabilities. The prognosis is graver for severe HIE, with a mortality risk of 60%, and nearly all survivors experiencing some form of disability.

Start Date01 Jan 2024

Sponsor / Collaborator

Armed Forces Hospital

CTR20140186 / RecruitingPhase 2

甲磺酸桂哌齐特注射液治疗急性脑梗死随机、双盲、安慰剂平行对照并剂量探索、多中心Ⅱ期临床试验

[Translation] A randomized, double-blind, placebo-controlled, dose-finding, multicenter phase II clinical trial of cinepazide mesylate injection in the treatment of acute cerebral infarction

以安慰剂为对照，评价甲磺酸桂哌齐特注射液减轻急性脑梗死患者残障程度的有效性和安全性，并探索最佳安全有效剂量和给药方法。

[Translation]

Using placebo as a control, evaluate the effectiveness and safety of cinepazide mesylate injection in reducing the degree of disability in patients with acute cerebral infarction, and explore the optimal safe and effective dose and administration method.

Start Date20 Jun 2013

Sponsor / Collaborator

Beijing Sihuan Pharmaceutical Co. Ltd.

[+1]

100 Clinical Results associated with Citicoline Sodium

100 Translational Medicine associated with Citicoline Sodium

100 Patents (Medical) associated with Citicoline Sodium

Literatures (Medical) associated with Citicoline Sodium

01 May 2021·Georgian medical news

[PHARMACEUTICAL DEVELOPMENT OF TABLETS WITH MODIFIED RELEASE OF CYTICOLINE AND MEMANTINE].

Article

Author: Salakhetdinov, D ; Sysuev, B

According to the WHO data, over 35 million people in the world suffer from severe forms of cognitive impairment. Due to the insufficient effectiveness of separate therapy for amyloid or vascular pathologies, an opinion is expressed about the prospects of combined pharmacotherapy of cognitive impairments. The aim of the study was the pharmaceutical development of the combined tablet dosage form formulation with modified release of citicoline and memantine for the treatment of cognitive impairments. Information bases (eLibrary, PubMed) were used, content analysis on State Register of Medicinal Remedies database (grls.rosminzdrav.ru). The compatibility assessment was carried out by stress experiments method in combination with chromatographic analysis. Comparative pharmacokinetic studies were carried out on rabbits. The justification of the pharmacological and clinical feasibility of the proposed fixed dose combination has been carried out, the objective advantage of which is the potentiation of the pharmacotherapeutic action due to the unidirectional effect of memantine and citicoline, and the expected effect is to improve cognition, functioning and behavior and / or slow down their deterioration. The use of the combination will allow achieving ease of treatment, reducing costs, and, accordingly, compliance. The choice of the optimal dosage form for the developed combination was carried out: a tablet containing two release methods: memantine - immediate release, citicoline - prolonged release. The compatibility of the pharmaceutical substances memantine hydrochloride and citicoline monosodium salt with each other and the excipients planned for use in the formulation has been experimentally revealed. Comparative pharmacokinetic studies of the developed combined drug have been carried out.

01 Dec 2020·BMC NeurologyQ4 · MEDICINE

Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial

Q4 · MEDICINE

ArticleOA

Author: Liu, Yafang ; Zheng, Shengzhe ; Zhao, Liang ; Liu, Ying ; Yi, Fei ; Gao, Junfeng ; Zhang, Qing ; Gao, Xiaoping ; Li, Xiaohong ; Cui, Liying ; Wei, Yan ; Bi, Hongye ; Gong, Tao ; Xiao, Bo ; Zhuang, Xiaorong ; Wang, Dong ; Ji, Yong ; Zhao, Liandong ; Cai, Xueli ; Hu, Weimin ; Fang, Qi ; Wei, Xiue ; Huang, Yining ; Han, Shugen ; Li, Luoqing ; Lü, Hua ; Wen, Guoqiang ; Zang, Dawei ; Ke, Kaifu ; Ni, Jun ; Zhou, Jinghua ; Qu, Xinhui ; Gao, Wei ; Li, Yaguo ; Chen, Huisheng ; Wang, Zhiyong ; Zhou, Chengfang ; Zhang, Tong ; Lin, Haiyan ; Wang, Jianfeng ; Tian, Chenglin ; Guo, Libin ; Tan, Guojun ; Ma, Qilin ; Dong, Hongliang ; Wang, Baojun ; Geng, Deqin ; Huang, Lina ; Yu, Xiaofei ; Li, Li ; Huang, Yonghua ; Wang, Shifang ; Zhang, Zhuobo ; Ding, Jianping ; Chen, Guofang ; Yao, Xiaoxi ; Wu, Jin ; Shao, Bei ; Yang, Hong ; Lu, Tianming ; Tang, Yamei ; Zhu, Runxiu ; Deng, Youqing ; Yang, Yi ; Li, Juntao ; Lu, Xiaodong

AbstractBackgroundIschemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 h of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.MethodsPatients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.ResultsIn total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤ 2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p = 0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p = 0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.ConclusionsThe results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.Trial registrationChinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827. Retrospectively registered June 13, 2019.

12 Aug 2020·Zhongguo zhen jiu = Chinese acupuncture & moxibustion

[Clinical observation on post-stroke oculomotor nerve palsy treated with the interaction of twelve meridian muscle regions and contralateral needling therapy].

Article

Author: Liu, Xiao-Xin ; Zhao, Ying ; Wu, Jiang-Ying

OBJECTIVETo observe the clinical effect on post-stroke oculomotor nerve palsy treated with the interaction of twelve meridian muscle regions and contralateral needling therapy.METHODSA total of 46 patients with post-stroke oculomotor nerve palsy were randomized into an observation group and a control group, 23 cases in each one. In the control group, the intramusclar injection of mecobalamine at the buttock region was given, 1 mL each time, once every two days, 3 times weekly. Besides, citicoline sodium capsules were prescribed for oral administration, 0.2 g each time, 3 times daily. In the observation group, on the base of the treatment as the control group, the interaction of twelve meridian muscle regions and contralateral needling therapy was supplemented. Acupoints on the health sides included Juliao (ST 3) and Hanyan (GB 4), acupoints on the affected side included Jingming (BL 1), Sibai (ST 2), Yangbai (GB 14), Cuanzhu (BL 2), Shangming (Extra), Sizhukong (TE 23), Tongziliao (GB 1) and bilateral Fengchi (GB 20), Quchi (LI 11), Pianli (LI 6), Waiguan (TE 5), Hegu (LI 4) were selected. The needles were retained for 30 min in each acupuncture treatment, once a day, 5 times weekly. The treatment for 4 weeks was required in the two groups. Before and after treatment, the score of cervical range of motion (CROM), pupil size, eye fissure width and eyeball mobility were observed in the patients of the two groups. The clinical effect was evaluated in the two groups.RESULTSAfter treatment, CROM scores and pupil size were reduced in the patients of the two groups (P<0.05), and the values in the observation group were lower than the control group (P<0.05). The eye fissure width and eyeball mobility were increased in the two groups (P<0.05), the eye fissure width and the mobility of the muscles of rectus internus, inferior rectus and inferior oblique in the observation group were larger than the control group (P<0.05). The effective rate was 82.6% (19/23) in the observation group, higher than 65.2% (15/23) in the control group (P<0.05).CONCLUSIONThe interaction of twelve meridian muscle regions and contrallateral needling therapy effectively relieves diplopia, pupil dilation, narrow eye fissure and limited eyeball mobility in the patients with post-stroke oculomotor nerve palsy.

100 Deals associated with Citicoline Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D03528	Citicoline Sodium	N06BX06	DB12153

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10 top approved records.

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Indication	Country/Location	Organization	Date
Brain Injuries	CN	Jiangsu Wuzhong Medicine Group Co., Ltd.	-

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