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

From ALZA Corporation, Mountain View, California (Dr Modi, Dr Dresser, Dr Desai) and Cognitive Drug Research Ltd, CDR House, Goring-on-Thames, UK (Mr Edgar, Dr Wesnes).

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, 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.

Key Words: dapoxetine • ethanol • pharmacokinetics • cognition

Address for reprints: Address for correspondence: Nishit B. Modi, PhD, ALZA Corporation, 1900 Charleston Road, Building M11-4A, Mountain View, CA 94043; e-mail: nmodi{at}alzus.jnj.com.