Last updated: 11/03/2018 16:02:35

Paxil CR Bioequivalence Study Brazil - Fed administration

GSK study ID
114035
See study documents
Clinicaltrials.gov ID
NCT01339247
See results summary
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: Relative bioavailability study between the formulations: Paroxetine 25 mg tablets with controlled release manufactured by GSK Mississauga and Paroxetine 25 mg tablets with controlled release manufactured by SmithKline Beecham (Cidra), fed administration in healthy volunteers of both genders
Trial description: The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the test drug and the reference drug (two periods of drug administration after standardized meals).
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

AUC_ss

Timeframe: Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)

Cmin_ss

Timeframe: Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)

Cmax_ss

Timeframe: Days 14 to 17 (period 1) and Days 23 to 24 (Period 2)

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico
  • Drug: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada
    • Enrollment:
    60
    Primary completion date:
    2009-16-11
    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)
    October 2009 to November 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 40 years
    Accepts healthy volunteers
    Yes
    • EXCLUSION CRITERIA:
    • hypersensitivity to the study drug or to compounds chemically related;
    Inclusion and exclusion criteria
    Inclusion criteria:
    • EXCLUSION CRITERIA:
    • hypersensitivity to the study drug or to compounds chemically related;
    • history of serious adverse events;
    • concurrent or recent use of other antidepressives, schizophrenia, anticonvulsant;
    • History of liver, heart, gastrointestinal or renal illness;
    • ECG findings not recommended according to the investigator judgement;
    • The volunteer ingests more than 5 cups of coffee or tea a day. INCLUSION CRITERIA:
    • Man and woman (since they are not pregnant or breastfeeding);
    • age between 18 and 40 years;
    • non-smoker and not addict;
    • mass index between 18,5 and 27;
    • good health conditions or without significant illness, by judgement of a legally qualified professional;
    • sign the informed consent.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Belo Horizonte, Minas Gerais, Brazil, 30110-014
    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2009-16-11
    Actual study completion date
    2009-16-11

    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 114035 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
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