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Repeat Dose Study of Controlled-Release Paroxetine Tablets and Immediate-Release Paroxetine Tablets in Healthy Japanese Male Subjects

NCT01000857 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-06-19

No results posted yet for this study

Summary

The primary purpose of this study is to compare the steady-state pharmacokinetic profile of paroxetine CR (controlled-release) at the dosage of 25mg/day using the proposed final market tablet of CR 25mg in Japan with that of standard paroxetine IR(immediate-release ) at the dosage of 20mg/day using the currently marketed tablet of IR 20mg in Japan.

Conditions

  • Depressive Disorder

Interventions

DRUG

Paroxetine CR and Paroxetine IR

Randomized, 2-period crossover repeat dosing of Paroxetine CR at 25 mg/day for 14 days and Paroxetine IR at 20 mg/day for 14 days in Japanese healthy male volunteers

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
2009-11-05
Primary Completion
2010-02-25
Completion
2010-02-25

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 NCT01000857 on ClinicalTrials.gov