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Pharmacokinetics of Dapoxetine Hydrochloride in Healthy Chinese, Japanese, and Caucasian Men
Author(s) -
Thyssen An,
Sharma Om,
Tianmei Si,
Aquilina Joseph W.,
Vandebosch An,
Wang SheanSheng,
Mudumbi Ramagopal,
Hsiao HsiuLing
Publication year - 2010
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270009359183
Subject(s) - premature ejaculation , pharmacokinetics , dosing , medicine , pharmacology , oral administration , psychology , psychoanalysis
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.