Pharmacokinetics of dapoxetine hydrochloride in healthy Chinese, Japanese, and Caucasian men

Journal of Clinical Pharmacology
An ThyssenHsiu-Ling Hsiao

Abstract

Dapoxetine is a short-acting selective serotonin reuptake inhibitor developed for the on-demand treatment of premature ejaculation and is approved in some European Union countries, as well as Mexico and Korea, for this indication. The pharmacokinetics of dapoxetine 30 mg and 60 mg in healthy Chinese (single dose), Japanese, and Caucasian men (single and multiple dose) were assessed in 2 studies. In the 3 ethnic groups, dapoxetine was rapidly absorbed following oral administration, with peak plasma concentrations evident approximately 1 hour after dosing, independent of dose, dosing frequency (single or multiple dosing), or ethnicity. Dapoxetine was eliminated in a biphasic manner with an apparent mean terminal half-life of 14 to 17 hours. There was a dose-proportional increase in dapoxetine maximum plasma concentration (C(max)) and area under concentration-time curves (AUCs). The single-dose pharmacokinetic parameters of dapoxetine metabolites were also similar for the 3 ethnic groups, as were the pharmacokinetics of dapoxetine and its metabolites following single and multiple dosing in Caucasian and Japanese men. Dapoxetine was well tolerated by all 3 ethnic groups.

References

Mar 8, 2000·International Journal of Clinical Pharmacology and Therapeutics·J A Johnson
Apr 22, 2008·The Journal of Sexual Medicine·Raymond C Rosen, Stanley Althof

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Citations

Apr 2, 2013·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Tae Kon KimHye Hyun Yoo
Oct 2, 2012·Therapeutic Advances in Urology·Chris G McMahon
Feb 15, 2016·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Thomas Y HsuehTung-Hu Tsai
Aug 24, 2013·International Journal of Urology : Official Journal of the Japanese Urological Association·Kyung Koo KangSukhyang Lee
Mar 18, 2011·Drugs in R&D·Peter R KoweyPeter M DiBattiste
Aug 2, 2011·Clinical Medicine Insights. Reproductive Health·Chris G McMahon

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