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

NCT00938184 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-06-19

No results posted yet for this study

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.

Conditions

  • Depressive Disorder

Interventions

DRUG

Paroxetine 12.5 milligrams tablet

Single dose of paroxetine 12.5 milligrams controlled release tablet will be administered orally.

DRUG

Paroxetine 25 milligrams tablet

Single dose of paroxetine 25 milligrams controlled release tablet will be administered orally.

DRUG

Paroxetine 50 milligrams tablet

Single dose of paroxetine 50 milligrams controlled release tablet (as two tablets of 25 milligrams) will be administered orally.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-14
Primary Completion
2009-09-02
Completion
2009-09-02

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00938184 on ClinicalTrials.gov