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The Journal of Clinical Pharmacology

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Single- and Multiple-Dose Pharmacokinetics of Dapoxetine Hydrochloride, a Novel Agent for the Treatment of Premature Ejaculation

Published:8 March 2013 DOI: 10.1177/0091270005284850 PMID: 16490806
Nishit B. Modi PhD, Mark J. Dresser PhD, Mary Simon MS, Denise Lin MS, Dhaval Desai MD, Suneel Gupta PhD

Abstract

Dapoxetine is a serotonin transporter inhibitor currently in development for the treatment of premature ejaculation. This randomized, 2-sequence, 2-treatment crossover study assessed the single- and multiple-dose pharmacokinetics of dapoxetine following once-daily administration of dapoxetine 30 mg and 60 mg to healthy male volunteers. Dapoxetine was rapidly absorbed following oral administration, with peak plasma concentrations reached approximately 1 hour after dosing; plasma concentrations after single doses of dapoxetine decreased rapidly to approximately 5% of peak concentrations by 24 hours. Elimination was biphasic, with an initial half-life of approximately 1.4 hours and a terminal half-life of approximately 20 hours. Dapoxetine showed time-invariant pharmacokinetics and dose proportionality between doses, and its pharmacokinetics was unaffected by multiple dosing. The pharmacokinetics of dapoxetine metabolites, desmethyldapoxetine and dapoxetine-N-oxide, was similarly unaffected by multiple dosing. There were no serious adverse events; the most commonly reported adverse events were diarrhea, dizziness, and nausea.

Substances (4)

Related products
Procduct Name CAS Molecular Formula Supplier Price
Dapoxetine hydrochloride 129938-20-1 C21H24ClNO 631 suppliers $5.00-$1880.00
Dapoxetine 119356-77-3 C21H23NO 374 suppliers Inquiry
Dapoxetine N-Oxide 1346603-24-4 C21H23NO2 46 suppliers Inquiry
Desmethyldapoxetine 1 suppliers Inquiry

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