NCT00406003

Brief Summary

The study was designed to describe the relationship between dose and pharmacokinetic parameters of paroxetine over the range of proposed dosage strengths of the paroxetine CR tablet (12.5 to 37.5 mg) as well as safety profile

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 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

March 24, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2006

Completed
7 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

1 month

First QC Date

November 30, 2006

Last Update Submit

September 27, 2017

Conditions

Depressive Disorder

Keywords

BRL029060/Paroxetine CRpharmacokineticssafety

Outcome Measures

Primary Outcomes (1)

  • To obtain pharmacokinetic parameters of paroxetine paroxetine CR tablet (12.5 to 37.5 mg) in healthy Chinese subjects

    Up to 32 days

Secondary Outcomes (1)

  • To describe Safety profile of healthy subjects when dosed with paroxetine controlled release

    Up to 32 days

Study Arms (6)

Subjects receiving treatment sequence ABC

EXPERIMENTAL

Eligible subjects will receive treatment sequence ABC; A= paroxetine 12.5 milligrams, B= paroxetine 25 milligrams, and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days.

Drug: Paroxetine controlled release tablet

Subjects receiving treatment sequence BAC

EXPERIMENTAL

Eligible subjects will receive treatment sequence BAC; B= paroxetine 25 milligrams, A= paroxetine 12.5 milligrams and C= paroxetine 37.5 milligrams separated by a wash-out period of 10 days.

Drug: Paroxetine controlled release tablet

Subjects receiving treatment sequence CBA

EXPERIMENTAL

Eligible subjects will receive treatment sequence CBA; C= paroxetine 37.5 milligrams, B= paroxetine 25 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days.

Drug: Paroxetine controlled release tablet

Subjects receiving treatment sequence BCA

EXPERIMENTAL

Eligible subjects will receive treatment sequence BCA; B= paroxetine 25 milligrams, C= paroxetine 37.5 milligrams and A= paroxetine 12.5 milligrams separated by a wash-out period of 10 days.

Drug: Paroxetine controlled release tablet

Subjects receiving treatment sequence CAB

EXPERIMENTAL

Eligible subjects will receive treatment sequence CAB; C= paroxetine 37.5 milligrams, A= paroxetine 12.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days.

Drug: Paroxetine controlled release tablet

Subjects receiving treatment sequence ACB

EXPERIMENTAL

Eligible subjects will receive treatment sequence ACB; A= paroxetine 12.5 milligrams, C= paroxetine 37.5 milligrams and B= paroxetine 25 milligrams separated by a wash-out period of 10 days.

Drug: Paroxetine controlled release tablet

Interventions

Paroxetine controlled release tabletDRUG

Paroxetine will be given as single dose, controlled release tablet with dosing strengths of 12.5, 25 and 37.5 milligrams in fasted state separated by a wash-out period of 10 days.

Subjects receiving treatment sequence ABCSubjects receiving treatment sequence ACBSubjects receiving treatment sequence BACSubjects receiving treatment sequence BCASubjects receiving treatment sequence CABSubjects receiving treatment sequence CBA

Eligibility Criteria

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

You may qualify if:

  • years healthy Chinese
  • 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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2006

First Posted

December 4, 2006

Study Start

March 24, 2006

Primary Completion

April 26, 2006

Study Completion

April 26, 2006

Last Updated

September 29, 2017

Record last verified: 2017-09

Locations

CN(1)