Document Detail


Pharmacokinetics of dapoxetine, a new treatment for premature ejaculation: Impact of age and effects of a high-fat meal.
MedLine Citation:
PMID:  16920897     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Dapoxetine is being developed as a treatment for premature ejaculation and has demonstrated rapid absorption and elimination in previous pharmacokinetic studies. Two open-label studies were conducted in healthy men: a parallel-group pharmacokinetic and safety study in young and elderly men and a randomized crossover food-effect study. Maximal plasma dapoxetine concentrations (C(max)) were similar in young and elderly men (338 and 310 ng/mL, respectively), as were the corresponding area under the plasma concentration versus time curve (AUC) values (2040 and 2280 ng x h/mL, respectively). When coadministered with food, C(max) was reduced by 11% (398 vs 443 ng/mL in the fed and fasted states, respectively), and the peak was delayed by approximately 30 minutes, indicating that food slowed the rate of absorption; however, systemic exposure to dapoxetine (ie, AUC) was not affected by food consumption. Thus, age or consumption of a high-fat meal has only a modest impact on dapoxetine pharmacokinetics in healthy men.
Authors:
Mark J Dresser; Dongwoo Kang; Peter Staehr; Shalini Gidwani; Cindy Guo; John P Mulhall; Nishit B Modi
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of clinical pharmacology     Volume:  46     ISSN:  0091-2700     ISO Abbreviation:  J Clin Pharmacol     Publication Date:  2006 Sep 
Date Detail:
Created Date:  2006-08-21     Completed Date:  2006-12-22     Revised Date:  2007-01-17    
Medline Journal Info:
Nlm Unique ID:  0366372     Medline TA:  J Clin Pharmacol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1023-9     Citation Subset:  IM    
Affiliation:
ALZA Corporation, 1900 Charleston Road, Building M11-4, Mountain View, CA 94043, USA. mdresser@alzus.jnj.com
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Aging / physiology*
Benzylamines / blood,  pharmacokinetics*,  therapeutic use*
Cross-Over Studies
Dietary Fats / pharmacology*
Ejaculation / drug effects*
Food
Humans
Male
Middle Aged
Naphthalenes / blood,  pharmacokinetics*,  therapeutic use*
Chemical
Reg. No./Substance:
0/Benzylamines; 0/Dietary Fats; 0/Naphthalenes; 119356-77-3/dapoxetine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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