NCT00406432

Brief Summary

The study was designed to assess the steady-state pharmacokinetic profile of paroxetine after 14 day repeated daily dosing of the controlled release tablet formulation (25 mg) in healthy Chinese subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2006

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2006

Completed
Last Updated

September 29, 2017

Status Verified

September 1, 2017

Enrollment Period

24 days

First QC Date

November 30, 2006

Last Update Submit

September 27, 2017

Conditions

Depressive Disorder

Keywords

BRL029060/Paroxetine CRpharmacokineticsrepeat dose

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetic parameters

    Up to 21 days

Secondary Outcomes (1)

  • safety parameters(adverse events, lab test results,vital signs,electrocardiograph)

    Up to 21 days

Study Arms (1)

Subjects receiving paroxetine

EXPERIMENTAL

Eligible subjects will receive single dose of paroxetine 25 milligrams controlled release formulation followed by wash-out period of 5 days. Subjects will receive multiple doses of paroxetine 25 milligrams for further 14 days.

Drug: Paroxetine Controlled Release Tablet

Interventions

Paroxetine Controlled Release TabletDRUG

Eligible subjects will receive paroxetine controlled release tablet with dose of 25 milligrams.

Subjects receiving paroxetine

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years healthy Chinese subjects
  • Body weight \> 50 kg
  • BMI between 19-25
  • serological negative for HIV, syphilis and hepatitis B and C
  • no abnormalities in ECG
  • Female with negative pregnancy and male has no plan to have a child during and 3 months after the study.

You may not qualify if:

  • History of chronic physical/mental disease, current disease and concomitant medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Beijing, 100730, China

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

May 9, 2006

Primary Completion

June 2, 2006

Study Completion

June 2, 2006

Last Updated

September 29, 2017

Record last verified: 2017-09

Locations

CN(1)