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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00406432
First Posted: December 4, 2006
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Depressive Disorder Drug: Paroxetine Controlled Release Tablet Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • pharmacokinetic parameters [ Time Frame: Up to 21 days ]

Secondary Outcome Measures:
  • safety parameters(adverse events, lab test results,vital signs,electrocardiograph) [ Time Frame: Up to 21 days ]

Enrollment: 12
Actual Study Start Date: May 9, 2006
Study Completion Date: June 2, 2006
Primary Completion Date: June 2, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Paroxetine Controlled Release Tablet
Eligible subjects will receive paroxetine controlled release tablet with dose of 25 milligrams.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406432


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

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00406432     History of Changes
Other Study ID Numbers: PCR104075
First Submitted: November 30, 2006
First Posted: December 4, 2006
Last Update Posted: September 29, 2017
Last Verified: September 2017

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
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors