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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00406432
First received: November 30, 2006
Last updated: May 31, 2012
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Pharmacokinetics
Depressive Disorder
 Drug: Paroxetine Controlled Release Tablet 25mg
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Steady-state Study to Assess the Pharmacokinetic Profile of Paroxetine After 14 Day Repeated Daily Dosing of the Controlled Release Paroxetine Tablet (25 mg) in Healthy Chinese Subjects

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • pharmacokinetic parameters

Secondary Outcome Measures:
  • safety parameters(adverse events, lab test results,vital signs,electrocardiograph)

Enrollment: 12
Study Start Date: May 2006
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Paroxetine Controlled Release Tablet 25mg
    Other Name: Paroxetine Controlled Release Tablet 25mg
  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406432

Locations
China
GSK Investigational Site
Beijing, China, 100730
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00406432     History of Changes
Other Study ID Numbers: PCR104075
Study First Received: November 30, 2006
Last Updated: May 31, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
BRL029060/Paroxetine CR
pharmacokinetics
repeat dose

Additional relevant MeSH terms:
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013