Last updated: 11/04/2018 10:12:31

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

GSK study ID
PCR104074
See study documents
Clinicaltrials.gov ID
NCT00406003
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: Up to 32 days

Secondary outcomes:

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

Timeframe: Up to 32 days

Interventions:
  • Drug: Paroxetine controlled release tablet
    • Enrollment:
    6
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Depressive Disorder
    Product
    paroxetine
    Collaborators
    Not applicable
    Study date(s)
    March 2006 to April 2006
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    19 - 45 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • 19-45 years healthy Chinese
    Inclusion and exclusion criteria
    Inclusion 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Beijing, China, 100730
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2006-26-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study PCR104074 can be found on the GSK Clinical Study Register.
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