Evidence map›Paper›PMID 27550655›Full record

ArticleEuropean journal of drug metabolism and pharmacokinetics2017

Multiple Dose Pharmacokinetics and Safety of Sulcardine Sulfate in Healthy Chinese Male Subjects: An Open-Label Phase I Clinical Study.

Wei Wang, Hong-Jie Qian, Liang Xin, Meng-Qi Zhang, Dong-Ying Lu, Jie-Mei Jin, Gang-Yi Liu, Jing-Ying Jia, Hong-Chao Zheng, Chen Yu and 3 more

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in European journal of drug metabolism and pharmacokinetics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 4 institutions in 1 country.

Wei WangEmergency Ward, Shanghai Xuhui Central Hospital and Zhongshan-Xuhui Hospital, Fudan University and Shanghai Clinical Center, Chinese Academy of Science, Shanghai, China.
Hong-Jie QianCentral Laboratory, Shanghai Xuhui Central Hospital and Zhongshan-Xuhui Hospital, Fudan University and Shanghai Clinical Center, Chinese Academy of Science, Shanghai, China.
Liang XinCentral Laboratory, Shanghai Xuhui Central Hospital and Zhongshan-Xuhui Hospital, Fudan University and Shanghai Clinical Center, Chinese Academy of Science, Shanghai, China.
Meng-Qi ZhangCentral Laboratory, Shanghai Xuhui Central Hospital and Zhongshan-Xuhui Hospital, Fudan University and Shanghai Clinical Center, Chinese Academy of Science, Shanghai, China.
Dong-Ying LuDepartment of Pharmacology, State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.
Jie-Mei JinCentral Laboratory, Shanghai Xuhui Central Hospital and Zhongshan-Xuhui Hospital, Fudan University and Shanghai Clinical Center, Chinese Academy of Science, Shanghai, China.
Gang-Yi LiuCentral Laboratory, Shanghai Xuhui Central Hospital and Zhongshan-Xuhui Hospital, Fudan University and Shanghai Clinical Center, Chinese Academy of Science, Shanghai, China.
Jing-Ying JiaCentral Laboratory, Shanghai Xuhui Central Hospital and Zhongshan-Xuhui Hospital, Fudan University and Shanghai Clinical Center, Chinese Academy of Science, Shanghai, China.
Hong-Chao ZhengDepartment of Cardiology, Shanghai Xuhui Central Hospital and Zhongshan-Xuhui Hospital, Fudan University and Shanghai Clinical Center, Chinese Academy of Science, Shanghai, China.
Chen YuCentral Laboratory, Shanghai Xuhui Central Hospital and Zhongshan-Xuhui Hospital, Fudan University and Shanghai Clinical Center, Chinese Academy of Science, Shanghai, China.
Yi-Ping WangDepartment of Pharmacology, State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China.
Fu ZhuDepartment of Cardiology, Shanghai Xuhui Central Hospital and Zhongshan-Xuhui Hospital, Fudan University and Shanghai Clinical Center, Chinese Academy of Science, Shanghai, China. zhufu@xh.sh.cn.
Yun LiuCentral Laboratory, Shanghai Xuhui Central Hospital and Zhongshan-Xuhui Hospital, Fudan University and Shanghai Clinical Center, Chinese Academy of Science, Shanghai, China. yliu@shxh-centerlab.com.
Fudan University · CNShanghai Xuhui Central Hospital · CNChinese Academy of Sciences · CNShanghai Institute of Materia Medica · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSulcardine sulfate is a novel antiarrhythmic agent with mechanism of action as a multi-ion channel blocker. Preclinical studies in animal models have demonstrated that sulcardine sulfate is efficacious in atrial and ventricular arrhythmias, and consequently, leads to the prevention of sudden cardiac death.

objectivesThis study was conducted in healthy Chinese male subjects to investigate the pharmacokinetic profile and safety of sulcardine sulfate after repeated oral dose administration at 200, 400, and 800 mg for 5 days.

methodsThirty-three male subjects were enrolled in this study. In the multiple dose phase, sulcardine sulfate was administered orally twice at the interval of q12 h since day 3. Sulcardine sulfate plasma concentration was determined using a validated LC-MS/MS method. Safety was assessed using clinical evaluation and AE monitoring.

resultsIn this repeated dose study, pharmacokinetic parameters (C

conclusionsPharmacokinetic characteristics of sulcardine sulfate were shown to be non-linear, with the modest accumulation upon repeated dosing, and sulcardine sulfate was safe and well tolerated.

Indexed as

Administration, OralAdolescentAdultAnti-Arrhythmia AgentsArea Under CurveChinaDose-Response Relationship, DrugHealthy VolunteersHumansMaleMiddle AgedSulfuric Acid EstersYoung AdultAnti-Arrhythmia Agentssulcardine sulfateSulfuric Acid Esters

Identifiers

PMID27550655
OpenAlexW2517659418

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.