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Main study objectives: To investigate the pharmacokinetic characteristics of the test preparation dapoxetine hydrochloride tablets and the reference preparation dapoxetine hydrochloride tablets in healthy adult male subjects in China after a single oral administration of 60 mg (fasting/after meals), and to verify the bioequivalence of the two preparations under fasting and after meals conditions. Secondary study objectives: To evaluate the safety of the test preparation and the reference preparation in healthy adult male subjects in China after a single oral administration of 60 mg (fasting/after meals).

Start Date20 Sep 2024

Sponsor / Collaborator

Guoda (Jilin) Pharmaceutical Group Co., Ltd

CTR20243114 / CompletedNot Applicable

盐酸达泊西汀片（60 mg）在中国健康成年男性受试者中的随机、开放、单次给药、两制剂、两序列、两周期、双交叉空腹和餐后状态下的生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of dapoxetine hydrochloride tablets (60 mg) in healthy Chinese adult male subjects under fasting and fed conditions

1.主要目的：以浙江莎普爱思药业股份有限公司生产的盐酸达泊西汀片（规格：60 mg）为受试制剂，Berlin-Chemie AG持证的盐酸达泊西汀片（商品名：必利劲®，规格：60 mg）为参比制剂，通过随机、开放、单次给药、两制剂、两序列、两周期、双交叉空腹和餐后临床试验来对比两种制剂在健康男性受试者体内的药代动力学行为，研究两制剂的人体生物等效性。次要目的：评价中国成年健康男性受试者单次空腹/餐后口服盐酸达泊西汀片受试制剂T和参比制剂R后的安全性。

[Translation]

1. Primary objective: Using dapoxetine hydrochloride tablets (specification: 60 mg) produced by Zhejiang Shapuaisi Pharmaceutical Co., Ltd. as the test preparation and dapoxetine hydrochloride tablets (trade name: Priligy®, specification: 60 mg) certified by Berlin-Chemie AG as the reference preparation, the pharmacokinetic behavior of the two preparations in healthy male subjects was compared through a randomized, open, single-dose, two-preparation, two-sequence, two-cycle, double-crossover fasting and postprandial clinical trial to study the bioequivalence of the two preparations in humans. Secondary objective: To evaluate the safety of the test preparation T and reference preparation R of dapoxetine hydrochloride tablets after a single fasting/postprandial oral administration in healthy Chinese adult male subjects.

Start Date19 Sep 2024

Sponsor / Collaborator

Zhejiang Shapuaisi Pharmaceutical Co. Ltd.

CTR20243204 / Active, not recruitingNot Applicable

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

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period crossover bioequivalence study of dapoxetine hydrochloride tablets in healthy Chinese adult male subjects under fasting and fed conditions

考察单次口服（空腹/餐后）受试制剂盐酸达泊西汀片和参比制剂盐酸达泊西汀片，在中国成年健康男性受试者体内的药代动力学特征，评估空腹与餐后条件下分别口服两种制剂的生物等效性。

[Translation]

The pharmacokinetic characteristics of the test preparation dapoxetine hydrochloride tablets and the reference preparation dapoxetine hydrochloride tablets after a single oral administration (fasting/fed) in healthy adult male subjects in China were investigated, and the bioequivalence of the two preparations was evaluated after oral administration under fasting and fed conditions.

Start Date13 Sep 2024

Sponsor / Collaborator

Shandong Xinhua Pharmaceutical Co., Ltd.

100 Clinical Results associated with Dapoxetine Hydrochloride

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100 Translational Medicine associated with Dapoxetine Hydrochloride

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100 Patents (Medical) associated with Dapoxetine Hydrochloride

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Literatures (Medical) associated with Dapoxetine Hydrochloride

12 Aug 2024·Zhongguo 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

Author: Sun, Dunpo ; Zhang, Lei ; Wang, Yisong ; Gao, Xuzhu ; Zhu, Shasha ; Lu, Meng

OBJECTIVETo explore the clinical effect of warm acupuncture with large-quantity moxibustion on primary premature ejaculation (kidney deficiency and liver stagnation).METHODSA 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.RESULTSAfter 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.CONCLUSIONWarm 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).

01 Aug 2024·Spectrochimica 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

Author: Ibrahim, Ahmed M ; Algohary, Ayman M ; Saraya, Roshdy E

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.

01 Aug 2024·Clinical Pharmacology in Drug Development

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

Article

Author: Zhang, Guangtao ; Zhang, Zhen ; Lian, Xianghua ; Li, Yumin ; 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.

100 Deals associated with Dapoxetine Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D03649	Dapoxetine Hydrochloride	G04BX14	DB04884

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Premature Ejaculation	SE	BERLIN-CHEMIE AG	17 Dec 2008

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Premature Ejaculation	Preclinical	US	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Premature Ejaculation	Preclinical	PL	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Premature Ejaculation	Preclinical	FR	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Premature Ejaculation	Preclinical	AU	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Premature Ejaculation	Preclinical	KR	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Premature Ejaculation	Preclinical	BE	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Premature Ejaculation	Preclinical	GB	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Premature Ejaculation	Preclinical	MX	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Premature Ejaculation	Preclinical	CA	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010
Premature Ejaculation	Preclinical	TW	Johnson & Johnson Pharmaceutical Research & Development LLC	01 Apr 2010

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01063855 (COUPLE, CTgov)	Phase 3	Premature Ejaculation \| Sexual Dysfunction \| Erectile Dysfunction	495	Placebo (PDE5I + Placebo (Baseline))	cymxnmdvgi(pdkkslrpzj) = ufvwnqrrcl ftjxtayflj (kdzwopquql, gmrivjeaze - qcyhffavbj)	-	04 Nov 2012
				Placebo (PDE5I + Placebo (Week 12))	cymxnmdvgi(pdkkslrpzj) = cskdrwzmwx ftjxtayflj (kdzwopquql, mqhebeptsw - ropiuwukoh)