Back to resultsA Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects
Primary Purpose
Depressive Disorder
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Paroxetine Controlled Release Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder focused on measuring BRL029060/Paroxetine CR, pharmacokinetics, repeat dose
Eligibility 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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects receiving paroxetine
Arm Description
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.
Outcomes
Primary Outcome Measures
pharmacokinetic parameters
Secondary Outcome Measures
safety parameters(adverse events, lab test results,vital signs,electrocardiograph)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00406432
Brief Title
A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 9, 2006 (Actual)
Primary Completion Date
June 2, 2006 (Actual)
Study Completion Date
June 2, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
BRL029060/Paroxetine CR, pharmacokinetics, repeat dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects receiving paroxetine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Paroxetine Controlled Release Tablet
Intervention Description
Eligible subjects will receive paroxetine controlled release tablet with dose of 25 milligrams.
Primary Outcome Measure Information:
Title
pharmacokinetic parameters
Time Frame
Up to 21 days
Secondary Outcome Measure Information:
Title
safety parameters(adverse events, lab test results,vital signs,electrocardiograph)
Time Frame
Up to 21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100730
Country
China
12. IPD Sharing Statement
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A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects
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