Pharmacokinetics, safety, and tolerability of sulcardine sulfate: an open-label, single-dose, randomized study in healthy Chinese subjects
文献类型：期刊论文
| 作者 | Chen, Qian1; Qian, Hong-jie1; Wang, Wei2; Zhang, Meng-qi1; Lu, Dong-ying3; Lu, Chuan1; Jin, Jie-mei1; Hu, Chao-ying1; Liu, Gang-yi1; Jia, Jing-ying1 |
| 刊名 | FUNDAMENTAL & CLINICAL PHARMACOLOGY
 |
| 出版日期 | 2017-02 |
| 卷号 | 31期号:1页码:120-125 |
| 关键词 | arrhythmia pharmacokinetics sulcardine sulfate tolerability |
| ISSN号 | 0767-3981 |
| DOI | 10.1111/fcp.12242 |
| 文献子类 | Article |
| 英文摘要 | Sulcardine sulfate (Sul) is a novel anti-arrhythmic agent as a potential treatment for atrial fibrillation and ventricular arrhythmias. This study was conducted to investigate the pharmacokinetic profile, safety, and tolerability of Sul in healthy Chinese subjects. In this open-label, single-dose, randomized study, 10 healthy subjects were assigned to receive Sul doses of 200, 400, and 800 mg under fasting conditions (Cohorts A, B, and C, respectively) or 400 mg under fed conditions (Cohort D). The study incorporated a crossover design, separated by a seven-day washout period. Blood samples were collected before treatment and at successive time intervals up to 48 h after treatment. Sul concentrations in plasma samples were determined using a validated LC-MS/MS method. Tolerability was determined by clinical evaluation and adverse event (AE) monitoring. Pharmacokinetic results demonstrated that C-max and AUC((0-t)) of Sul increased with an increasing dose. The mean t(1/2) values for Cohorts A, B, and C were 16.85, 17.66, and 11.87 h, respectively. No statistically significant differences were observed between men and women for the main pharmacokinetic parameters, with the exception of t(1/2) in Cohorts B and C. No significant differences were observed in the absorption and bioavailability of Sul between the fed and fasted states (P > 0.05). Four subjects reported mild AEs during the study. No serious AEs were reported. Sul was shown to be safe and well tolerated in healthy Chinese subjects. Pharmacokinetics studies demonstrated that Sul has adequate oral absorption and bioavailability properties. |
| WOS关键词 | SUDDEN CARDIAC DEATH ; ATRIAL-FIBRILLATION |
| 资助项目 | Ministry of Science and Technology of China[2010ZX09502-003] ; Shanghai Committee of Science and Technology, China[15DZ2291800] |
| WOS研究方向 | Pharmacology & Pharmacy |
| 语种 | 英语 |
| WOS记录号 | WOS:000393766300010 |
| 出版者 | WILEY-BLACKWELL |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/275651]  |
| 专题 | 成果转移转化处 中科院受体结构与功能重点实验室 新药研究国家重点实验室 药理学第一研究室 |
| 通讯作者 | Liu, Yun |
| 作者单位 | 1.Fudan Univ, Zhongshan Xuhui Hosp, Shanghai Xuhui Cent Hosp, Cent Lab, Shanghai 200031, Peoples R China; 2.Fudan Univ, Zhongshan Xuhui Hosp, Shanghai Xuhui Cent Hosp, Dept Emergency, Shanghai 200031, Peoples R China; 3.Chinese Acad Sci, State Key Lab Drug Res, Shanghai Inst Mat Med, Shanghai 201203, Peoples R China; 4.Fudan Univ, Dept Cardiol, Shanghai Xuhui Cent Hosp, Zhongshan Xuhui Hosp, Shanghai 200031, Peoples R China; 5.Fudan Univ, Dept Clin Pharmacol, Zhong Shan Hosp, Shanghai 200032, Peoples R China |
| 推荐引用方式 GB/T 7714 | Chen, Qian,Qian, Hong-jie,Wang, Wei,et al. Pharmacokinetics, safety, and tolerability of sulcardine sulfate: an open-label, single-dose, randomized study in healthy Chinese subjects[J]. FUNDAMENTAL & CLINICAL PHARMACOLOGY,2017,31(1):120-125. |
| APA | Chen, Qian.,Qian, Hong-jie.,Wang, Wei.,Zhang, Meng-qi.,Lu, Dong-ying.,...&Liu, Yun.(2017).Pharmacokinetics, safety, and tolerability of sulcardine sulfate: an open-label, single-dose, randomized study in healthy Chinese subjects.FUNDAMENTAL & CLINICAL PHARMACOLOGY,31(1),120-125. |
| MLA | Chen, Qian,et al."Pharmacokinetics, safety, and tolerability of sulcardine sulfate: an open-label, single-dose, randomized study in healthy Chinese subjects".FUNDAMENTAL & CLINICAL PHARMACOLOGY 31.1(2017):120-125. |
入库方式： OAI收割
来源：上海药物研究所
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