Dapoxetine(Yuhan Corp.)(Dapoxetine(Yuhan Corp.)) - 药物靶点：SERT_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Dapoxetine、IMD dapoxetine

+ [1]

靶点

SERT

作用机制

SERT抑制剂(5-羟色胺转运体抑制剂)

治疗领域

泌尿生殖系统疾病

在研适应症-

非在研适应症

早泄

原研机构

Yuhan Corp.

在研机构-

非在研机构

Yuhan Corp.

最高研发阶段终止临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

结构/序列

分子式C21H23NO

InChIKeyUSRHYDPUVLEVMC-FQEVSTJZSA-N

CAS号119356-77-3

关联

24

项与 Dapoxetine(Yuhan Corp.) 相关的临床试验

IRCT20230222057495N8

/ RecruitingN/A

Bioequivalence study of dapoxetine 60 mg tablet of Sami Saz pharmaceutical company compared to dapoxetine 60 mg sample of Menarini company in England on healthy volunteers

开始日期2023-08-11

申办/合作机构-

IRCT20220111053692N12

/ RecruitingN/AIIT

Bioequivalence study of Dapoxetine 60 mg Tablet (Pharma Chemie Pharmaceutical Company) versus Priligy 60 mg (ALZA corporation) Tablet in healthy volunteers

开始日期2023-06-24

申办/合作机构-

ChiCTR2200066928

/ SuspendedN/AIIT

The effect of combination treatment with acupuncture and dapoxetine on lifelong premature ejaculation: a randomized controlled trial

开始日期2023-01-01

申办/合作机构

广州中医药大学第一附属医院

100 项与 Dapoxetine(Yuhan Corp.) 相关的临床结果

登录后查看更多信息

100 项与 Dapoxetine(Yuhan Corp.) 相关的转化医学

登录后查看更多信息

100 项与 Dapoxetine(Yuhan Corp.) 相关的专利（医药）

登录后查看更多信息

272

项与 Dapoxetine(Yuhan Corp.) 相关的文献（医药）

2024-08-01·Clinical Pharmacology in Drug Development

Bioequivalence Assessment of Two Dapoxetine Hydrochloride Formulations in Healthy Chinese Males Under Fasted and Fed Conditions

Article

作者: Zhang, Guangtao ; Zhang, Zhen ; Li, Yumin ; Lian, Xianghua ; Wang, Cheng ; Xie, Jizhen

AbstractThis study evaluated the bioequivalence of the newly developed dapoxetine hydrochloride tablet relative to the marketed reference product by comparing their pharmacokinetic profiles under fasted and fed conditions. A total of 60 healthy Chinese male subjects participated in a single‐center, 2‐period, 2‐sequence, randomized, open‐label, self‐crossover study with a washout period of 14 days, 30 in the fasted group and 30 in the fed group. Following a single 30‐mg oral dose of the test or reference dapoxetine formulation, blood samples were collected before dosing to 72 hours after dosing. Liquid chromatography‐tandem mass spectrometry was performed to measure plasma concentration of dapoxetine and determine pharmacokinetic parameters through noncompartmental analysis. The vital signs and adverse events were also monitored during the study. The 90% confidence intervals of the geometric mean ratios for maximum plasma concentration, area under the plasma concentration‐time curve from time 0 to the last concentration time, and area under the plasma concentration‐time curve from time 0 extrapolated to infinity of the 2 dapoxetine formulations completely fell within the regulatory criteria for bioequivalence of 80%‐125%. In addition, both dapoxetine hydrochloride formulations were generally well tolerated. The generic dapoxetine hydrochloride tablet was bioequivalent to the marketed reference product in healthy Chinese men with no discernible safety differences.

2024-07-01·Journal of Chromatography B

Toxicologic analysis of 35 drugs in post mortem human blood samples with focus on antihypertensive and antiarrhythmic drugs

Article

作者: Szewczyk, Anne ; Müller, Alexander ; Iwersen-Bergmann, Stefanie ; Jungen, Hilke ; Ondruschka, Benjamin ; Bickel, Julian

Antiarrhythmic and antihypertensive drugs are frequently encountered in post mortem analysis, and the question may arise as to whether they were administered in therapeutic doses, and if they were taken in accidental, intentional, or suicidal overdose scenarios. Therefore, a novel analytical method was developed and validated for the quantification of 35 drugs with toxicological relevance, including antihypertensive and antiarrhythmic drugs (ajmaline, amlodipine, amiodarone, atenolol, bisoprolol, carvedilol, clonidine, desethylamiodarone, diltiazem, donepezil, doxazosin, dronedarone, esmolol, flecainide, lercanidipine, lidocaine, metoprolol, nebivolol, nimodipine, pindolol, prajmaline, propafenone, propranolol, sotalol, urapidil, and verapamil), as well as other medications commonly found in combination (sildenafil, tadalafil, atorvastatin, clopidogrel, dapoxetine, memantine, pentoxifylline, rivastigmine, and ivabradine). The method enables simultaneous identification and quantification in blood samples using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Validation exhibited excellent linearity across the concentration range for all analytes. Precision and accuracy were within acceptable limits, with bias and relative standard deviation (RSD) values consistently below 9 % and 10 %, respectively. Selectivity and specificity assessments confirmed the absence of any interference from contaminants or co-extracted drugs. The method demonstrated very high sensitivity, with limits of detection (LOD) as low as 0.01 ng/ml and limits of quantification (LOQ) as low as 0.04 ng/ml. Extraction recovery exceeded 57.5 % for all analytes except atenolol, and matrix effects were <17 % for all analytes except pindolol. Processed sample stability evaluations revealed consistent results with acceptable deviations for all analytes. In addition, the method was specifically tested for the use in post mortem analysis. The applicability of our method was demonstrated by the analysis of two authentic human autopsy blood samples.

2024-05-31·Journal of Chromatographic Science

Analytical Quality Risk Assessment and Design of Experiments to Green HPTLC Method for Simultaneous Estimation of Sildenafil Citrate and Dapoxetine Hydrochloride

Article

作者: Prajapati, Pintu B ; Pulusu, Veerashakar ; Shah, Shailesh A ; Sheta, Bhavesh M

AbstractA green and robust high-performance thin-layer chromatographic method has been developed for the simultaneous estimation of sildenafil citrate and dapoxetine hydrochloride. A fractional factorial design was applied for analytical quality risk assessment of potential analytical risk factors. The identified critical analytical risk factors were optimized using the design of experiment-based response surface analysis by full factorial design. The analytical design space was navigated for the optimization of the method and the control strategy was framed for low-risk life-cycle management of the chromatographic method. The chromatographic analysis of sildenafil and dapoxetine was carried out on a TLC plate coated with silica gel G60 F254 using n-butanol:ethyl acetate:ethanol (8.0 + 2.0 + 0.5, v/v) as mobile phase. The chromatographic peaks of sildenafil and dapoxetine were found to be at Rf 0.29 and 0.69, respectively. The method was found to be accurate, precise, robust, specific and sensitive. The fixed-dose combinations of sildenafil and dapoxetine were assayed and results were found in compliance with their labeled claim. The present method was developed using safe and eco-friendly organic solvents for the safety of analysts and the protection of the environment. The greenness profiles of developed and reported methods were evaluated using the NEMI scale and AGREE software.

100 项与 Dapoxetine(Yuhan Corp.) 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	Dapoxetine(Yuhan Corp.)	G04BX14	DB04884

研发状态

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
早泄	临床3期	-	Yuhan Corp.	-
早泄	临床3期	-	Yuhan Corp.	-

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


AUA2024	N/A	早泄	-	Dapoxetine 30 mg+mirodenafil 50 mg	(鹹簾夢窪襯齋觸製淵製) = 鑰壓膚憲願觸蓋膚構窪廠膚廠蓋觸衊鹽鹹蓋夢 (糧鹽簾鏇齋夢製顧鑰膚, 23.0 ~ 400.0)	积极	2024-05-01
				OLNP-05	(鹹簾夢窪襯齋觸製淵製) = 衊鏇齋醖願廠醖憲窪憲廠膚廠蓋觸衊鹽鹹蓋夢 (糧鹽簾鏇齋夢製顧鑰膚, 140.0 ~ 410.0)
MP45-07 (AUA2020)	N/A	早泄	182	Dapoxetine	鑰窪蓋憲範壓網膚憲糧(艱衊願窪顧獵網衊網顧) = 艱夢糧獵艱築襯糧蓋艱繭壓繭築夢築範製淵選 (夢繭鬱範衊廠蓋顧窪齋 )	-	2020-04-01
AUA2016	N/A	早泄一线	117	Dapoxetine 30 mg	(顧選獵選餘構艱簾顧選) = 6.3% vs. 3.2% 齋獵鹽壓積淵選製遞繭 (積構鏇糧廠淵構範遞醖 ) 更多	-	2016-04-01
				Sertraline 50 mg