| Effect of dapoxetine on the pharmacokinetics and hemodynamic effects of tamsulosin in men on a stable dose of tamsulosin. | |
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MedLine Citation:
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PMID: 18832488 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The tolerability of dapoxetine, a short-acting selective serotonin reuptake inhibitor being developed for premature ejaculation, was evaluated when coadministered with tamsulosin. Adult men on a stable dose of tamsulosin were randomized to also receive dapoxetine 30 or 60 mg, or placebo, in a crossover design. Supine and standing vital signs were measured on days 1 and 7. Plasma samples were collected for measurement of tamsulosin, dapoxetine, and dapoxetine metabolites. Coadministration of dapoxetine with tamsulosin did not alter orthostatic profiles or affect the incidence of orthostatic hypotension. Tamsulosin and dapoxetine pharmacokinetics were not altered. Adverse events were reported by 5.4%, 10.9%, and 23.2% of participants receiving tamsulosin with placebo, dapoxetine 30 mg, and dapoxetine 60 mg, respectively. The most common adverse events were diarrhea, dizziness, headache, and nausea. Therefore, dapoxetine had no clinically important effects on the pharmacokinetics or orthostatic profile of tamsulosin in men on a stable tamsulosin regimen. |
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Authors:
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N B Modi; S Kell; J Aquilina; D Rivas |
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Publication Detail:
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Type: Clinical Trial, Phase I; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2008-10-02 |
Journal Detail:
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Title: Journal of clinical pharmacology Volume: 48 ISSN: 0091-2700 ISO Abbreviation: J Clin Pharmacol Publication Date: 2008 Dec |
Date Detail:
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Created Date: 2008-12-02 Completed Date: 2009-02-23 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0366372 Medline TA: J Clin Pharmacol Country: United States |
Other Details:
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Languages: eng Pagination: 1438-50 Citation Subset: IM |
Affiliation:
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Clinical Pharmacology, ALZA Corporation, Mountain View, California USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adrenergic alpha-Antagonists
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adverse effects,
pharmacokinetics,
pharmacology Adult Aged Area Under Curve Benzylamines / adverse effects, pharmacokinetics*, pharmacology Cross-Over Studies Dizziness / chemically induced Double-Blind Method Half-Life Headache / chemically induced Hemodynamics / drug effects* Humans Hypotension, Orthostatic / chemically induced Male Middle Aged Naphthalenes / adverse effects, pharmacokinetics*, pharmacology Receptors, Adrenergic, alpha-1 / antagonists & inhibitors Serotonin Uptake Inhibitors / adverse effects, metabolism, pharmacokinetics, pharmacology Sulfonamides / adverse effects, pharmacokinetics*, pharmacology Syncope, Vasovagal / chemically induced |
| Chemical | |
Reg. No./Substance:
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0/Adrenergic alpha-Antagonists; 0/Benzylamines; 0/Naphthalenes; 0/Receptors, Adrenergic, alpha-1; 0/Serotonin Uptake Inhibitors; 0/Sulfonamides; 106133-20-4/tamsulosin; 119356-77-3/dapoxetine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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