更新于：2024-12-20
Dapoxetine Hydrochloride
盐酸达泊西汀
更新于：2024-12-20
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 瑞典 (2008-12-17), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构
分子式C21H24ClNO |
InChIKeyIHWDIQRWYNMKFM-BDQAORGHSA-N |
CAS号129938-20-1 |
关联
96
项与 盐酸达泊西汀 相关的临床试验国源国药（广东）制药集团有限公司研制的盐酸达泊西汀片与原研参比制剂在中国健康受试者中进行的单中心、随机、开放、两制剂、空腹和餐后、单次给药、两周期、双交叉设计的生物等效性研究
盐酸达泊西汀片在中国健康成年男性受试者中的生物等效性研究
评价盐酸达泊西汀片在中国成年健康男性受试者中的一项单中心、随机、开放、空腹和餐后条件下单次给药、两制剂、两周期交叉的生物等效性研究
100 项与 盐酸达泊西汀 相关的临床结果
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100 项与 盐酸达泊西汀 相关的转化医学
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100 项与 盐酸达泊西汀 相关的专利（医药）
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93
项与 盐酸达泊西汀 相关的文献（医药）2024-08-12Zhongguo zhen jiu = Chinese acupuncture & moxibustion
[Primary premature ejaculation of kidney deficiency and liver stagnation treated with warm acupuncture of large-quantity moxibustion: a randomized controlled trial].
Article
作者: Lu, Meng ; Sun, Dunpo ; Gao, Xuzhu ; Zhang, Lei ; Wang, Yisong ; Zhu, Shasha
OBJECTIVE:
To explore the clinical effect of warm acupuncture with large-quantity moxibustion on primary premature ejaculation (kidney deficiency and liver stagnation).
METHODS:
A total of 240 patients with primary premature ejaculation (kidney deficiency and liver stagnation) were randomly divided into a warm acupuncture group (80 cases, 5 cases dropped out), an acupuncture group (80 cases, 4 cases dropped out) and a western medication group (80 cases, 6 cases dropped out). In the warm acupuncture group, a large quantity of moxibustion was delivered after acupuncture at Baihui (GV 20), Qihai (CV 6), Guanyuan (CV 4) and Zhongji (CV 3), as well as bilateral Fengchi (GB 20), lateral line 3 of forehead (MS 4), neishengzhiqi (TF2), Ganshu (BL 18), Shenshu (BL 23), and etc. One treatment with warm acupuncture took 40 min, once daily; five treatments were given per week and 4 weeks of treatment was required. In the acupuncture group, moxibustion was not delivered, and the rest operation of acupuncture was same as the warm acupuncture group. In the western medication group, dapoxetine hydrochloride tablets were administered orally, 30 mg each time, taken with warm water 1 h to 3 h before sexual intercourse. Medication was administered at most once within 24 h, twice per week, and 6 times within 4 weeks. Before and after treatment, the score of TCM symptoms, the score of premature ejaculation diagnostic tool (PEDT), intravaginal ejaculation latency time (IELT) and the serum sex hormone content (testosterone [T], luteinizing hormone [LH] and follicule stimulating hormone [FSH]) were observed and the clinical effect was evaluated in the three groups.
RESULTS:
After treatment, the scores for less duration of intercourse (<1 min), post-ejaculation fatigue, low spirit and decreased libido, and the total scores of TCM symptoms, as well as PEDT scores were reduced when compared with those before treatment in each group (P<0.01, P<0.05), and IELT was prolonged (P<0.01) in the three groups. The serum T content was increased when compared with that before treatment in the warm acupuncture group (P<0.05). After treatment, in comparison with the acupuncture group and the western medication group, the scores for post-ejaculation fatigue, soreness and weakness in the lumbar region and knee joints, decreased libido, insomnia, dream-disturbed sleep and frequent nocturnal enuresis, as well as the total score of TCM symptoms were lower (P<0.05, P<0.01) and the serum T content was increased (P<0.05) in the warm acupuncture group. When compared with the acupuncture group, PEDT scores were lower and IELT prolonged in the warm acupuncture group and the western medication group (P<0.05, P<0.01). The total effective rate was 82.7% (62/75) in the warm acupuncture group, higher than that of the acupuncture group (68.4%, 52/76) and the western medication group (64.9%, 48/74, P<0.05) respectively.
CONCLUSION:
Warm acupuncture with large-quantity moxibustion ameliorates the clinical symptoms and increases intravaginal ejaculation latency time and the levels of sex hormone in the patients with primary premature ejaculation (kidney deficiency and liver stagnation).
2024-08-01Clinical 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 ; Li, Yumin ; Wang, Cheng ; Xie, Jizhen ; Zhang, Zhen ; Lian, Xianghua
Abstract:
This 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.
2024-08-01SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY
A sustainable model for the simultaneous determination of tadalafil and dapoxetine hydrochloride in their binary mixture: Overcoming the challenges of environmental, operational, and instrumental variability for spectral data
Article
作者: Saraya, Roshdy E ; Ibrahim, Ahmed M ; Algohary, Ayman M
This study employed functional principal component analysis (FPCA) and covariate design of experiments (DoE) to mitigate the susceptibility of chemometric methods to unexpected variations stemming from operational and instrumental factors. A comparative analysis with partial least squares (PLS) revealed that our proposed approach effectively reduced variability across different analysts, days, and instruments. Specifically, FPCA was utilized to compress available spectral wavelength information, while covariate DoE aided in selecting an optimal training set within the experimental space. Subsequently, PLS was applied for the simultaneous determination of tadalafil (TD) and dapoxetine hydrochloride (DP) in their binary mixture. Validation of the proposed method through accuracy profiles demonstrated its reliability, paving the way for its application in pharmaceutical analysis.
100 项与 盐酸达泊西汀 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 早泄 | 瑞典 | 2008-12-17 |
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10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 勃起功能障碍 | 临床3期 | 美国 | 2010-04-01 | |
| 勃起功能障碍 | 临床3期 | 阿根廷 | 2010-04-01 | |
| 勃起功能障碍 | 临床3期 | 澳大利亚 | 2010-04-01 | |
| 勃起功能障碍 | 临床3期 | 比利时 | 2010-04-01 | |
| 勃起功能障碍 | 临床3期 | 加拿大 | 2010-04-01 | |
| 勃起功能障碍 | 临床3期 | 法国 | 2010-04-01 | |
| 勃起功能障碍 | 临床3期 | 马来西亚 | 2010-04-01 | |
| 勃起功能障碍 | 临床3期 | 墨西哥 | 2010-04-01 | |
| 勃起功能障碍 | 临床3期 | 波兰 | 2010-04-01 | |
| 勃起功能障碍 | 临床3期 | 俄罗斯 | 2010-04-01 |
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临床结果
临床结果
适应症
分期
评价
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N/A | - | 願憲簾壓製鬱顧簾範壓(糧範窪夢膚網築衊鬱顧) = 醖衊醖遞選簾淵鹽襯觸 築醖觸觸艱觸製構壓壓 (淵顧糧廠衊鑰淵淵蓋艱, 23.0 ~ 400.0) | 积极 | 2024-05-01 | |||
OLNP-05 | 願憲簾壓製鬱顧簾範壓(糧範窪夢膚網築衊鬱顧) = 顧繭顧齋鬱窪餘鏇鑰壓 築醖觸觸艱觸製構壓壓 (淵顧糧廠衊鑰淵淵蓋艱, 140.0 ~ 410.0) | ||||||
临床3期 | 495 | Placebo | 餘網遞簾顧積簾鏇艱鏇(築獵構鑰選淵構鏇淵觸) = Incidence of TEAEs was 20.0% and 29.6% in placebo- and dapoxetine-treated subjects, respectively (P = 0.0135) 繭願膚醖範糧廠顧壓廠 (鏇構願廠窪觸鹹遞鏇艱 ) 更多 | 积极 | 2013-09-01 | ||
Dapoxetine 30mg | |||||||
临床3期 | 495 | Placebo (PDE5I + Placebo (Baseline)) | 構廠壓觸鹽鑰顧築衊鑰(顧糧願簾鹹積廠蓋願憲) = 糧選網糧膚遞觸鬱齋鏇 艱顧窪糧壓窪餘糧憲獵 (鏇窪艱餘範鑰齋襯齋繭, 繭鏇範壓選網鏇餘顧獵 ~ 鹹積製壓簾鏇築壓鹹鑰) | - | 2012-11-04 | ||
Placebo (PDE5I + Placebo (Week 12)) | 構廠壓觸鹽鑰顧築衊鑰(顧糧願簾鹹積廠蓋願憲) = 壓積艱製齋窪鏇窪醖選 艱顧窪糧壓窪餘糧憲獵 (鏇窪艱餘範鑰齋襯齋繭, 窪範網壓蓋壓構窪選構 ~ 選製壓築膚醖觸網簾餘) |
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