Last updated: 11/04/2018 12:29:05

GSK372475 Bioequivalence Study

GSK study ID
SND110117
Clinicaltrials.gov ID
NCT00488098
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: An open label, randomized, parallel groups, bioequivalence study to compare a single oral dose of GSK372475B or GSK372475C in male and female healthy volunteers.
Trial description: The study is to show the new salt formulation of GSK372475 is equivalent to the old salt formulation of GSK372475.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

GSK372475 plasma level at AUC0-72, AUC0-inf, CMax and TMax

Timeframe: at predose, 0.5,1-24, 36,48,60,72,96 and 1-4 weeks post dose.

Secondary outcomes:

Adverse events

Timeframe: all visits

vitals (all visits) + ECG

Timeframe: at screening,Day-1, predose, 1,6,24,48,72 and week 2 post dose.

labs

Timeframe: at screening and 2 weeks post dose

Interventions:
  • Drug: GSK372475
    • Enrollment:
    66
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Healthy Subjects, Depressive Disorder
    Product
    GSK372475
    Collaborators
    Not applicable
    Study date(s)
    July 2007 to November 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 45 years
    Accepts healthy volunteers
    Yes
    • Healthy Males/Females aged 18-45 years
    • Non-smokers
    • Use of oral contraception
    • Positive breath alcohol and drug screen
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy Males/Females aged 18-45 years
    • Non-smokers
    • BMI 19-30 kg.m2
    • QTc<450msec
    Exclusion criteria:
    • Use of oral contraception
    • Positive breath alcohol and drug screen
    • Regular alcohol consumption
    • Current psychiatric illness or within 1 year.
    • History of GI, hepatic or renal disease
    • Uncontrolled hypertension

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M1L 4S4
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-05-11

    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

    Additional information
    Not applicable
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