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A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects

NCT ID: NCT00406432

Last Updated: 2017-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-09

Study Completion Date

2006-06-02

Brief Summary

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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.

Detailed Description

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Conditions

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Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects receiving paroxetine

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.

Group Type EXPERIMENTAL

Paroxetine Controlled Release Tablet

Intervention Type DRUG

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

Interventions

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Paroxetine Controlled Release Tablet

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 19-45 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.

Exclusion Criteria

* History of chronic physical/mental disease, current disease and concomitant medication
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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PCR104075

Identifier Type: -

Identifier Source: org_study_id