Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00406003

First received: November 30, 2006

Last updated: May 31, 2012

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 30, 2006

Last Updated Date

May 31, 2012

Start Date ^ICMJE

March 2006

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00406003 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Single Dose Pharmacokinetic (PK) Study Of Paroxetine CR(12.5-37.5mg) In Healthy Chinese Subjects

Official Title ^ICMJE

A Randomized, Open, Three-period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Single Dosing of Each Enteric-coated Geomatrix Control Release Tablet Strength (12.5, 25, 37.5mg) in Healthy Chinese Subjects

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pharmacokinetics
Depressive Disorder

Intervention ^ICMJE

Drug: Paroxetine controlled Release 12.5mg, 25mg and37.5mg

Other Names:

Paroxetine controlled Release 12.5mg
25mg and37.5mg

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2006

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

19-45 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.

Exclusion criteria:

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

Gender

Both

Ages

19 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00406003

Other Study ID Numbers ^ICMJE

PCR104074

Has Data Monitoring Committee

Not Provided

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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