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Dapoxetine Has No Pharmacokinetic or Cognitive Interactions With Ethanol in Healthy Male Volunteers
Author(s) -
Modi Nishit B.,
Dresser Mark,
Desai Dhaval,
Edgar Christopher,
Wesnes Keith
Publication year - 2007
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270006297229
Subject(s) - premature ejaculation , pharmacokinetics , crossover study , placebo , pharmacology , medicine , ethanol , anesthesia , psychology , chemistry , alternative medicine , organic chemistry , pathology , psychoanalysis
Dapoxetine is being investigated for the treatment of premature ejaculation. This study evaluated the potential pharmacokinetic and cognitive interactions of dapoxetine 60 mg with ethanol 0.5 g/kg in a single‐center, double‐blind, randomized, placebo‐controlled crossover study in healthy adult male participants (n = 24). Dapoxetine was rapidly absorbed and eliminated; peak concentrations were noted 1.47 hours after administration and decreased with an alpha half‐life of 1.33 hours and a terminal half‐life of 15.6 hours. Pharmacokinetic parameters (C max , AUC ∞ , t 1/2 , and t max ) of dapoxetine were not altered with concurrent ethanol consumption. Furthermore, coadministration of dapoxetine did not affect the pharmacokinetics of ethanol or potentiate the cognitive and subjective effects of ethanol.