Regulatory Status of Dapoxetine in Spain

If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov.

Dapoxetine hydrochloride

As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well. Janssen Research & Development, LLCCompletedSexual Dysfunction, Physiological EjaculationGermany, Spain, Portugal, Finland, Sweden, Austria Johnson & Johnson Pharmaceutical Research & Development...CompletedSexual Dysfunction Ejaculation Sohag UniversityCompletedVitamin D, Vitamin B12 and Folic Acid Among Patients With Premature EjaculationEgypt Abant Izzet Baysal UniversityCompletedEjaculatory Dysfunction Sexual Dysfunction Male Premature (Early) EjaculationTurkey (Türkiye) PfizerCompletedEjaculationItaly, Spain, Australia, Austria, Canada, Czech Republic, France, Germany, Israel, Norway, Poland, Sweden, Turkey, Netherlands Institute for the Study of Urological Diseases,...RecruitingErectile DysfunctionGreece Centro Universitario de Ciencias de la Salud, MexicoUnknownObesity and Erectile DysfuntionMexico Saint Petersburg State University, RussiaRecruitingErectile DysfunctionRussian Federation Futura Medical Developments Ltd.CompletedErectile DysfunctionUnited States, Bulgaria, Georgia, Poland Product Avanafil CAS#330784-47-9; Vildagliptin CAS#274901-16-5Documentation: DMF, WC,COA Specification: in-house Product Oseltamivir Phosphate CAS#204255-11-8For the treatment and prevention of influenza A and B in adults and children one year and older. Specification: USP, EP, BP, CHP Documentation: DMF, WC, COA, GMP Product Tadalafil CAS#171596-29-5For the treatment of erectile dysfunction.

Specification: USP, EP, BP Documentation: DMF, WC, COA, GMP Product DAPOXETINE HYDROCHLORIDEThis product is indicated for premature ejaculation(PE) in men aged 18 to 64 years.

Before taking dapoxetine

[11] Dapoxetine, given 1–3 hours before sexual episode, prolongs IELT and increases the sense of control and sexual satisfaction in men of 18 to 64 years of age with PE. Since PE is associated with personal distress and interrelationship difficulty, dapoxetine provides help for men with PE to overcome this condition. With no drug approved specifically for treatment for PE in the US and some other countries, other SSRIs such as fluoxetine, paroxetine, sertraline, fluvoxamine, and citalopram have been used off-label to treat PE. Waldinger's meta-analysis shows that the use of these conventional antidepressants increases IELT two- to nine-fold above baseline, compared to three- to eight-fold when dapoxetine is used. [11] However, these SSRIs may need to be taken daily to achieve meaningful efficacy, and their comparatively longer half-lives increase the risk of drug accumulation and a corresponding increase of adverse effects such as reduced libido. Product OSELTAMIVIR PHOSPHATEFor the treatment and prevention of influenza A and B in adults and children one year and older. Product Sildenafil CitrateFor the treatment of penile erectile dysfunction in men. Product TADALAFILFor the treatment of erectile dysfunction for men.

Sildenafil Citrate + Dapoxetine HCl DC Grade

The method was linear within the concentration range of 5.0–600 ng/mL for Dapoxetine in human plasma. Short analytical run was achieved with 1.6 min run time. Intra-day and inter-day accuracy was between 97 and 106% with precision (CV, %) of ≤ 5% achieved across all the quality control samples. Dapoxetine was stable in several conditions with recovery rates > 90%. This method was utilized successfully in clinical pharmacokinetic study following oral administration of 60 mg Dapoxetine tablets in 36 healthy male subjects.

Study Locations

The result for all 90% confidence intervals were within the preset ranges. The method proved to be highly reproducible and sensitive and thus can be employed in bioequivalence studies and large scale sample analysis of Dapoxetine. Unlock Import & Export insights by typing your unique search query According to Dapoxetine Hydrochloride export data, buyers can access detailed shipment records based on customs details across multiple countries. It provides information such as product description, HS code, quantity, value, origin country, port details, and buyer-supplier names. The top Dapoxetine Hydrochloride exporting countries are UKRAINE, VIETNAM.

Plan for Individual participant data (IPD)

Our global Dapoxetine Hydrochloride export data is sourced from over 200+ country and 150+ Indian ports (sea, air, ICDs & SEZs) Trade professionals frequently use India Dapoxetine Hydrochloride export data to evaluate sourcing trends and shipment volumes. This data offers visibility into India Dapoxetine Hydrochloride export data statistics, helping exporters assess which ports handle specific product categories more efficiently. Regulated under the India Dapoxetine Hydrochloride customs export data, these insights ensure compliance, safety, and transparency in cargo handling. With access to the Dapoxetine Hydrochloride shipment export data, businesses gain clarity on shipment frequency, origin countries, and cargo movement. Insights derived from India Dapoxetine Hydrochloride exporters' statistics further help in understanding trade performance and identifying the top export ports. Product Vardenafil HydrochlorideFor the treatment of penile erectile dysfunction in men. Brochure PRODUCT LIST OF PHARMA JITAIThe APIs and intermediates which producing by ourself included in this this product list. Dapoxetine is an oral medication used for treatment of premature ejaculation (PE) in men aged (18–64 years). In this study, we present a validated, precise and sensitive method for determination of dapoxetine in human plasma by liquid chromatography/ electrospray ionization-tandem mass spectrometry. Dapoxetine and the internal standard (Dapoxetine- d6) were extracted from plasma via liquid–liquid extraction (LLE). The LC separation was performed utilizing ACE C8 (4.6 X50) mm, 5 µm column. The mobile phase was composed of acetonitrile and buffer (0.01 M Ammonium acetate +0.02% dapoxetine sildenafil online Formic acid solution) (85:15, v/v). The method was linear within the concentration range of 5.0–600 ng/mL for Dapoxetine in human plasma. Short analytical run was achieved with 1.6 min run time. Intra-day and inter-day accuracy was between 97 and 106% with precision (CV, %) of ≤ 5% achieved across all the quality control samples. Dapoxetine was stable in several conditions with recovery rates > 90%. This method was utilized successfully in clinical pharmacokinetic study following oral administration of 60 mg Dapoxetine tablets in 36 healthy male subjects.

Althernative Medicine

[13] Dapoxetine, though, is generally categorized as a fast-acting SSRI. The result for all 90% confidence intervals were within the preset ranges. The method proved to be highly reproducible and sensitive and thus can be employed in bioequivalence studies and large scale sample analysis of Dapoxetine. Unlock Import & Export insights by typing your unique search query According to Dapoxetine Hydrochloride export data, buyers can access detailed shipment records based on customs details across multiple countries. It provides information such as product description, HS code, quantity, value, origin country, port details, and buyer-supplier names. The top Dapoxetine Hydrochloride exporting countries are UKRAINE, VIETNAM. Our global Dapoxetine Hydrochloride export data is sourced from over 200+ country and 150+ Indian ports (sea, air, ICDs & SEZs) Trade professionals frequently use India Dapoxetine Hydrochloride export data to evaluate sourcing trends and shipment volumes. This data offers visibility into India Dapoxetine Hydrochloride export data statistics, helping exporters assess which ports handle specific product categories more efficiently. Regulated under the India Dapoxetine Hydrochloride customs export data, these insights ensure compliance, safety, and transparency in cargo handling. With access to the Dapoxetine Hydrochloride shipment export data, businesses gain clarity on shipment frequency, origin countries, and cargo movement. Insights derived from India Dapoxetine Hydrochloride exporters' statistics further help in understanding trade performance and identifying the top export ports. Additionally, specialised India Dapoxetine Hydrochloride export statistics support containerized and multi-modal exports, strengthening the overall export infrastructure.

Grab the Special Offer from Eximpedia and Start Exploring Global Import-Export Trade Data. Learn How our platform works in just 20 minutes! Free Import-Export Sample data-One Click Away! Check out the most commonly asked questions below. Dapoxetine Hydrochloride exporters data on Eximpedia includes shipment-level records, exporter details, importing countries, HS codes, quantities, and export values. Users can analyse Dapoxetine Hydrochloride export trade data to understand sourcing patterns, demand trends, dapoxetine 5mg and buyer behaviour across global markets. Eximpedia’s Dapoxetine Hydrochloride export statistics are derived from verified customs and shipping records. Our data is regularly updated to ensure accuracy, helping users rely on real trade movements rather than estimates or outdated reports. Yes, we provide a verified list of Dapoxetine Hydrochloride exporters based on actual Dapoxetine Hydrochloride export shipment records. This allows importers and suppliers to connect with genuine buyers actively exporting Dapoxetine Hydrochloride in specific countries. The Dapoxetine Hydrochloride HSN code helps classify Dapoxetine Hydrochloride products correctly during customs clearance. Using the correct HS code Dapoxetine Hydrochloride export classification ensures compliance with regulations, accurate duty calculation, and smooth international trade operations.

Regulatory history

Yes, we offer Dapoxetine Hydrochloride buyers data by country, allowing users to compare export volumes, supplier countries, and demand trends across multiple markets. This is ideal for exporters planning market expansion. exporters, importers, traders, logistics companies, researchers, and policymakers can all benefit from Eximpedia’s Dapoxetine Hydrochloride exporters database by gaining accurate insights into the global Dapoxetine Hydrochloride export market. See all that you can accomplish with Eximpedia Dapoxetine, sold under the brand name Priligy among others, is a selective serotonin reuptake inhibitor (SSRI) used for the treatment of premature ejaculation (PE) in men ages 18 to 64 years old. [3][4][5] Dapoxetine works by inhibiting the serotonin transporter, increasing serotonin's action at the postsynaptic cleft, and as a consequence promoting ejaculatory delay.

Mechanism of action

[6] As a member of the SSRI family, dapoxetine was initially created as an antidepressant. However, unlike other SSRIs, dapoxetine is absorbed and eliminated rapidly in the body. Its fast-acting property makes it suitable for the treatment of PE, but not as an antidepressant. Originally created by Eli Lilly pharmaceutical company, dapoxetine was sold to Johnson & Johnson in 2003 and submitted as a New Drug Application to the US Food and Drug Administration (FDA) for the treatment of PE in 2004. [8] Dapoxetine dapoxetin sildenafil is sold in several European and Asian countries, and in Mexico.

Brochure PRODUCT LIST OF PHARMA JITAI

In the US, dapoxetine has been in phase III development. In May 2012, US-based Furiex Pharmaceuticals reached an agreement with ALZA Corp and Janssen Pharmaceuticals to market dapoxetine in the United States, Japan, and Canada, while selling the rights to market the drug in Europe, most of Asia, Africa, Latin America, and the Middle East to Menarini. Randomized, double-blind, placebo-controlled trials have confirmed the efficacy of dapoxetine for the treatment of PE. [10] Different dosages have different impacts on different types of PE. Dapoxetine 60 mg significantly improves the mean intravaginal ejaculation latency time (IELT) compared to that of dapoxetine 30 mg in men with lifelong PE, but no difference is seen in men with acquired PE. Dapoxetine Hydrochloride export shipment data helps businesses track real-time trade flows, identify active buyers, analyse competitor exports, and monitor supply chain routes.

Study Overview

Additionally, specialised India Dapoxetine Hydrochloride export statistics support containerized and multi-modal exports, strengthening the overall export infrastructure. Grab the Special Offer from Eximpedia and Start Exploring Global Import-Export Trade Data. Learn How our platform works in just 20 minutes! Free Import-Export Sample data-One Click Away! Check out the most commonly asked questions below.

Drug and device information, study documents

Dapoxetine Hydrochloride exporters data on Eximpedia includes shipment-level records, exporter details, importing countries, HS codes, quantities, and export values. Users can analyse Dapoxetine Hydrochloride export trade data to understand sourcing patterns, demand trends, dapoxetine 5mg and buyer behaviour across global markets. Eximpedia’s Dapoxetine Hydrochloride export statistics are derived from verified customs and shipping records. Our data is regularly updated to ensure accuracy, helping users rely on real trade movements rather than estimates or outdated reports. Yes, we provide a verified list of Dapoxetine Hydrochloride exporters based on actual Dapoxetine Hydrochloride export shipment records.

Chemical Formula

This allows importers and suppliers to connect with genuine buyers actively exporting Dapoxetine Hydrochloride in specific countries. The Dapoxetine Hydrochloride HSN code helps classify Dapoxetine Hydrochloride products correctly during customs clearance. Using the correct HS code Dapoxetine Hydrochloride export classification ensures compliance with regulations, accurate duty calculation, and smooth international trade operations. Dapoxetine Hydrochloride export shipment data helps businesses track real-time trade flows, identify active buyers, analyse competitor exports, and monitor supply chain routes. Our data-driven dashboard supports smarter sourcing and sales strategies. Our data-driven dashboard supports smarter sourcing and sales strategies. Yes, we offer Dapoxetine Hydrochloride buyers data by country, allowing users to compare export volumes, supplier countries, and demand trends across multiple markets. This is ideal for exporters planning market expansion.

Safety Advice

If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well. Janssen Research & Development, LLCCompletedSexual Dysfunction, Physiological EjaculationGermany, Spain, Portugal, Finland, Sweden, Austria Johnson & Johnson Pharmaceutical Research & Development...CompletedSexual Dysfunction Ejaculation Sohag UniversityCompletedVitamin D, Vitamin B12 and Folic Acid Among Patients With Premature EjaculationEgypt Abant Izzet Baysal UniversityCompletedEjaculatory Dysfunction Sexual Dysfunction Male Premature (Early) EjaculationTurkey (Türkiye) PfizerCompletedEjaculationItaly, Spain, Australia, Austria, Canada, Czech Republic, France, Germany, Israel, Norway, Poland, Sweden, Turkey, Netherlands Institute for the Study of Urological Diseases,...RecruitingErectile DysfunctionGreece Centro Universitario de Ciencias de la Salud, MexicoUnknownObesity and Erectile DysfuntionMexico Saint Petersburg State University, RussiaRecruitingErectile DysfunctionRussian Federation Futura Medical Developments Ltd.CompletedErectile DysfunctionUnited States, Bulgaria, Georgia, Poland Product Avanafil CAS#330784-47-9; Vildagliptin CAS#274901-16-5Documentation: DMF, WC,COA Specification: in-house Product Oseltamivir Phosphate CAS#204255-11-8For the treatment and prevention of influenza A and B in adults and children one year and older. Specification: USP, EP, BP, CHP Documentation: DMF, WC, COA, GMP Product Tadalafil CAS#171596-29-5For the treatment of erectile dysfunction. Specification: USP, EP, BP Documentation: DMF, WC, COA, GMP Product DAPOXETINE HYDROCHLORIDEThis product is indicated for premature ejaculation(PE) in men aged 18 to 64 years.

Chemical Names

Product OSELTAMIVIR PHOSPHATEFor the treatment and prevention of influenza A and B in adults and children one year and older. Product Sildenafil CitrateFor the treatment of penile erectile dysfunction in men. Product TADALAFILFor the treatment of erectile dysfunction for men. Product Vardenafil HydrochlorideFor the treatment of penile erectile dysfunction in men. Brochure PRODUCT LIST OF PHARMA JITAIThe APIs and intermediates which producing by ourself included in this this product list.

Product Vardenafil Hydrochloride

Dapoxetine is an oral medication used for treatment of premature ejaculation (PE) in men aged (18–64 years). In this study, we present a validated, precise and sensitive method for determination of dapoxetine in human plasma by liquid chromatography/ electrospray ionization-tandem mass spectrometry. Dapoxetine and the internal standard (Dapoxetine- d6) were extracted from plasma via liquid–liquid extraction (LLE). The LC separation was performed utilizing ACE C8 (4.6 X50) mm, 5 µm column. The mobile phase was composed of acetonitrile and buffer (0.01 M Ammonium acetate +0.02% dapoxetine sildenafil online Formic acid solution) (85:15, v/v). exporters, importers, traders, logistics companies, researchers, and policymakers can all benefit from Eximpedia’s Dapoxetine Hydrochloride exporters database by gaining accurate insights into the global Dapoxetine Hydrochloride export market. See all that you can accomplish with Eximpedia Dapoxetine, sold under the brand name Priligy among others, is a selective serotonin reuptake inhibitor (SSRI) used for the treatment of premature ejaculation (PE) in men ages 18 to 64 years old. [3][4][5] Dapoxetine works by inhibiting the serotonin transporter, increasing serotonin's action at the postsynaptic cleft, and as a consequence promoting ejaculatory delay. [6] As a member of the SSRI family, dapoxetine was initially created as an antidepressant.

• Dapoxetine was introduced to the Spanish market after regulatory approval.
• It can enhance sexual satisfaction by delaying ejaculation.
• Dapoxetine has a rapid onset of action, typically within hours.
• The pharmacy distribution of dapoxetine in Spain is widespread.
• Dapoxetine prescriptions in Spain increased in recent years.
• It is considered a safe option when used responsibly.
• Patients are advised to avoid alcohol when taking dapoxetine.

However, unlike other SSRIs, dapoxetine is absorbed and eliminated rapidly in the body. Its fast-acting property makes it suitable for the treatment of PE, but not as an antidepressant. Originally created by Eli Lilly pharmaceutical company, dapoxetine was sold to Johnson & Johnson in 2003 and submitted as a New Drug Application to the US Food and Drug Administration (FDA) for the treatment of PE in 2004. [8] Dapoxetine dapoxetin sildenafil is sold in several European and Asian countries, and in Mexico. In the US, dapoxetine has been in phase III development.

• Dapoxetine is a medication used to treat premature ejaculation in men.
• Spain approved dapoxetine for prescription to improve sexual confidence.
• The drug works by increasing serotonin levels to delay ejaculation.
• Dapoxetine is available in Spain under various brand names.
• It is typically taken 1 to 3 hours before sexual activity.
• Dapoxetine is considered a short-acting selective serotonin reuptake inhibitor.
• The medication has been studied for its safety and efficacy in Spain.

In May 2012, US-based Furiex Pharmaceuticals reached an agreement with ALZA Corp and Janssen Pharmaceuticals to market dapoxetine in the United States, Japan, and Canada, while selling the rights to market the drug in Europe, most of Asia, Africa, Latin America, and the Middle East to Menarini. Randomized, double-blind, placebo-controlled trials have confirmed the efficacy of dapoxetine for the treatment of PE. [10] Different dosages have different impacts on different types of PE. Dapoxetine 60 mg significantly improves the mean intravaginal ejaculation latency time (IELT) compared to that of dapoxetine 30 mg in men with lifelong PE, but no difference is seen in men with acquired PE. [11] Dapoxetine, given 1–3 hours before sexual episode, prolongs IELT and increases the sense of control and sexual satisfaction in men of 18 to 64 years of age with PE. Since PE is associated with personal distress and interrelationship difficulty, dapoxetine provides help for men with PE to overcome this condition. With no drug approved specifically for treatment for PE in the US and some other countries, other SSRIs such as fluoxetine, paroxetine, sertraline, fluvoxamine, and citalopram have been used off-label to treat PE. Waldinger's meta-analysis shows that the use of these conventional antidepressants increases IELT two- to nine-fold above baseline, compared to three- to eight-fold when dapoxetine is used. [11] However, these SSRIs may need to be taken daily to achieve meaningful efficacy, and their comparatively longer half-lives increase the risk of drug accumulation and a corresponding increase of adverse effects such as reduced libido. [13] Dapoxetine, though, is generally categorized as a fast-acting SSRI.