title: Dapoxetine has no pharmacokinetic or cognitive interactions with ethanol in healthy male volunteers.
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 (C(max), AUC(infinity), 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.
authors.affiliation: ALZA Corporation, 1900 Charleston Road, Building M11-4A, Mountain View, CA 94043, USA. nmodi@alzus.jnj.com
authors.forename: Nishit B
authors.initials: NB
authors.lastname: Modi
authors.forename: Mark
authors.initials: M
authors.lastname: Dresser
authors.forename: Dhaval
authors.initials: D
authors.lastname: Desai
authors.forename: Christopher
authors.initials: C
authors.lastname: Edgar
authors.forename: Keith
authors.initials: K
authors.lastname: Wesnes
mesh_terms: D000328:Adult; D019540:Area Under Curve; D001247:Asthenia / Q000139:chemically induced; D001596:Benzylamines / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D002492:Central Nervous System Depressants / Q000008:administration & dosage / Q000493:pharmacokinetics; D003071:Cognition / Q000187:drug effects*; D018592:Cross-Over Studies; D006970:Disorders of Excessive Somnolence / Q000139:chemically induced; D004311:Double-Blind Method; D004347:Drug Interactions; D000431:Ethanol / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006207:Half-Life; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D009281:Naphthalenes / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D009483:Neuropsychological Tests; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D013607:Tablets; D015354:Vision, Low / Q000139:chemically induced
chemical_list: D001596:Benzylamines; D002492:Central Nervous System Depressants; D000431:Ethanol; D009281:Naphthalenes; D017367:Selective Serotonin Reuptake Inhibitors; D013607:Tablets; C522496:dapoxetine-N-oxide; C080599:mono-desmethyldapoxetine; C080598:dapoxetine