[Translation] A randomized, blinded, placebo-controlled, dose-escalating, intravenous infusion clinical trial of the safety, tolerability and pharmacokinetic properties of brozopentane sodium in healthy volunteers

评估健康志愿者静脉滴注布罗佐喷钠的耐受性、安全性及药代动力学特性。

[Translation]

To evaluate the tolerability, safety, and pharmacokinetic properties of intravenous brozopentane sodium in healthy volunteers.

Start Date26 Jun 2024

Sponsor / Collaborator

Hangzhou Ausia Biological Technology Co. Ltd.

[+1]

CTR20192145

/ CompletedPhase 2

多中心、随机、双盲、安慰剂平行对照评估不同剂量注射用布罗佐喷钠治疗急性缺血性卒中的临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating different doses of Brozopent Sodium for Injection in the treatment of acute ischemic stroke

评价不同剂量注射用BZP对比安慰剂治疗急性缺血性卒中的安全性和可行性，并初步探讨其有效性，为Ⅲ期临床试验设计提供依据

[Translation]

To evaluate the safety and feasibility of different doses of BZP for injection compared with placebo in the treatment of acute ischemic stroke, and to preliminarily explore its effectiveness, so as to provide a basis for the design of Phase III clinical trials

Start Date27 Mar 2020

Sponsor / Collaborator

Zhejiang Ausun Pharmaceutical Co., Ltd.

[+1]

CTR20171254

/ CompletedPhase 1

随机、单盲、安慰剂对照、剂量递增、多次静脉滴注布罗佐喷钠的安全性、耐受性及药代动力学

[Translation] Safety, tolerability and pharmacokinetics of brozopentane sodium in a randomized, single-blind, placebo-controlled, dose-escalating, multiple intravenous infusion

评估健康志愿者多次静脉滴注布罗佐喷钠的耐受性、安全性及药代动力学特性

[Translation]

To evaluate the tolerability, safety and pharmacokinetic characteristics of multiple intravenous infusions of brozopentane sodium in healthy volunteers

Start Date11 Oct 2017

Sponsor / Collaborator

Zhejiang Ausun Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Brozopentyl Sodium

100 Translational Medicine associated with Brozopentyl Sodium

100 Patents (Medical) associated with Brozopentyl Sodium

202

Literatures (Medical) associated with Brozopentyl Sodium

01 Jul 2025·Journal of Hazardous Materials

Interpretable machine learning-based insights into early-life endocrine disruptor exposure and small vulnerable newborns

Article

Author: Yang, Luhan ; Xue, Jingchuan ; Xi, Jianya ; Yang, Lan ; Miao, Maohua ; Zhang, Tao ; Liang, Hong ; Wang, Ziliang ; Zhang, Henglin ; Zhao, Yanan ; Cai, Yanpeng ; Liu, Yuxian ; Zhang, Guanglan

Early-life exposure to endocrine-disrupting chemicals (EDCs) may contribute to small vulnerable newborns, including conditions such as being small for gestational age (SGA) and preterm birth (PTB), yet evidence remains limited. This study, which is based on 739 mother-infant pairs in the Chinese Jiashan Birth Cohort (2016-2018), including 39 SGA and 38 PTB cases, employed interpretable machine learning to elucidate the isolated effects of 34 EDCs on SGA and PTB risk and sex interactions in a multi-substance exposure context. Extra Trees and CatBoost classifiers performed best for SGA and PTB, respectively, achieving sensitivities of 0.60 and 0.73 and specificities of 0.82 and 0.97. For SGA, key predictors included bisphenol A (2,3-dihydroxypropyl) glycidyl ether (BADGE-H₂O), benzophenone (bZp), bisphenol A bis(2,3-dihydroxypropyl) ether (BADGE-2H₂O), propyl paraben (PrP), and 2-methylthio-benzothiazole (2-Me-S-BTH). Lower exposures to BADGE-H₂O, bZp, and BADGE-2H₂O (concentrations below 0.21, 4.22, and 0.93 μg·g^-1 creatinine, respectively) and higher exposure to 2-Me-S-BTH (above 0.15 μg·g^-1 creatinine) were both associated with increased SGA risk. Notably, BADGE-H₂O, BADGE-2H₂O, and PrP showed significant interactions with fetal sex. For PTB, key predictors included ethyl paraben (EtP), methyl paraben (MeP), bZp, BADGE-H₂O, and 1H-benzotriazole (1-H-BTR). Lower BADGE-H₂O and higher EtP and bZp exposures increased PTB risk (< 0.10 and > 0.01 and 0.60 μg·g^-1 creatinine, respectively). Male fetuses appeared more susceptible to EtP and MeP, and female fetuses were more susceptible to 1-H-BTR. Bayesian kernel machine regression was performed to compare the results. This study demonstrated the potential of interpretable machine learning in environmental epidemiology.

01 Apr 2025·Epilepsia

When patients with Creutzfeldt–Jakob disease are misdiagnosed as having nonconvulsive status epilepticus

Review

Author: Gélisse, Philippe ; Crespel, Arielle

AbstractContemporary studies report nonconvulsive status epilepticus (NCSE) in Creutzfeldt–Jakob disease (CJD), based on benzodiazepine (BZP)‐responsive epileptiform discharges on the electroencephalogram (EEG), with the following false syllogism: (1) intravenous (IV) administration of BZPs usually suppress ictal activity in NCSE; (2) in CJD, periodic sharp wave complexes (PSWCs) are suppressed by IV BZPs; (3) therefore, these patients have NCSE. This is a simplistic and invalid conclusion, because authors of 20th‐century science reports have clearly shown that IV BZPs, short‐acting barbiturates, and drugs with no antiseizure effects, such as chloral hydrate and IV naloxone, suppress PSWCs, but patients fall asleep with no clinical improvement. In contrast, IV methylphenidate transiently improves both the EEG and clinical states. Unlike NCSE, which is unlikely to be stopped by external stimuli, PSWCs can be transiently stopped by sensory or painful stimulation. Since the end of the 1970s, the effect of spontaneous sleep on the disappearance of PSWCs has been well documented, with a description of a cycling alternating pattern. Phase A features periodic discharges and is associated with increased arousal, whereas phase B exhibits a reduction or suppression of the PSWCs and is associated with a reduction in the arousal level and hypotonia (non‐rapid eye movement sleep). When considering the use of IV BZP administration during EEG as a diagnostic test, the sequence of disappearance of PSWCs at sleep onset and reappearance after each stimulation or sleep apnea episode is compelling evidence against NCSE, as is the observation of a pattern of stimulus‐induced wakefulness with transient improvement of the EEG. The cycling alternating pattern during sleep and reactivity to sensory or painful stimulation disappear with increasing disease severity; however, this occurs in the later stages of the disease, where there is no diagnostic doubt.

01 Mar 2025·Journal of Chromatography B

Detection and application of 40 piperazine compounds in hair suitable for rapid separation of isomers

Article

Author: Wang, Xin ; Yang, Shuo ; Shi, Yan ; Liu, Jinting ; Pei, Lina ; Xie, Wanting ; Gao, Guoqing ; Zhou, Liying ; Yun, Keming

A simple and sensitive procedure, using benzylpiperazine-D₇ (BZP-D₇) as an internal standard, has been developed and validated for the qualitative and quantitative analysis of 40 piperazines in hair. Drugs were extracted from 20 mg of hair with 0.5 mL of methanol containing 1 ng/mL BZP-D₇. After ultrasonication, centrifugation and filtration, the supernatant was analyzed by ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) operating in the multiple reaction monitoring mode. Piperazine-type substances were separated in 10 min on a T₃ column using a mobile phase gradient composed of A (water, formic acid 0.1 %, acetonitrile 5 %, and 20 mmol/L ammonium acetate) and B (acetonitrile). The developed and validated method showed good selectivity, sensitivity (limit of detection: 0.5-20 pg/mg and lower limit of quantitation: 5-20 pg/mg), linearity (R² > 0.99), accuracy, precision, and dilution integrity. The method also showed good recovery and acceptable matrix effects for most of the targeted compounds. This analytical approach was successfully applied for the identification and quantification of piperazine-type substances in hair from rat and guinea pig.

100 Deals associated with Brozopentyl Sodium

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Ischemic Stroke	Phase 2	China	Zhejiang Ausun Pharmaceutical Co., Ltd.	27 Mar 2020
Acute Ischemic Stroke	Preclinical	China	Zhengzhou University	27 Mar 2020

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