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

This study has been completed.

First Received: November 30, 2006 Last Updated: October 9, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00406003

Purpose

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

Condition	Intervention	Phase
Pharmacokinetics	Drug: Paroxetine controlled Release 12.5mg, 25mg and37.5mg	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine Mesylate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	12
Study Start Date:	March 2006
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	19 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406003

Locations

China
GSK Investigational Site
Beijing, China, 100730

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	PCR104074
Study First Received:	November 30, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00406003 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by GlaxoSmithKline:

BRL029060/Paroxetine CR
pharmacokinetics
safety

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Paroxetine
Serotonin Uptake Inhibitors

Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009