Dapoxetine Has No Pharmacokinetic or Cognitive Interactions With Ethanol in Healthy Male Volunteers


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Abstract

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 (Cmax, AUC(X), t1/2, and t1/2 of dapoxetine were not altered with concurrent ethanol consumption. Furthermore, coadmin-istration of dapoxetine did not affect the pharmacokinetics of ethanol or potentiate the cognitive and subjective effects of ethanol.

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