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Single Dose Study of Controlled-Release Paroxetine Tablets in Healthy Japanese Male Subjects

Depressive Disorder Clinical Trial

Official title:
An Open Label, Randomized, Three-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Single Doses of the Controlled-release Paroxetine Tablets at the Dose Levels of 12.5, 25 and 50mg in Healthy Japanese Male Subjects

Clinical Trial Summary

The primary purpose of this study is to to assess the pharmacokinetics of paroxetine after single doses of paroxetine CR at the dose levels of 12.5, 25 and 50mg in healthy Japanese male volunteers.

Clinical Trial Description

This clinical trial is to characterize the pharmacokinetic profile after single oral doses of the proposed final market tablet formulations of paroxetine CR in Japan (the 12.5mg and 25mg tablets), at the dose levels of 12.5, 25 and 50mg in the healthy male Japanese volunteers. Treatment sequence of the 3 dose levels in each subject is randomized. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00938184
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date July 14, 2009
Completion date September 2, 2009
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