Last updated: 11/04/2018 08:48:11

Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers

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GSK study ID
LBI108617
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Clinicaltrials.gov ID
NCT00449774
EudraCT ID
2006-004313-17
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, randomised, single-dose, parallel-group study to demonstrate bioequivalence of two formulations and the effect of food and water on one formulation of lamotrigine in healthy male and female volunteers
Trial description: This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Lamotrigine AUC(0-inf) and Cmax. Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours

Timeframe: Time points when measures are taken : 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 and 144 hours

Secondary outcomes:

Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above. Adverse events, changes in biochemistry, haematology, urinalysis parameters, electrocardiogram parameters, blood pressure and heart rate at various times during the study.

Timeframe: Serum lamotrigine AUC(0-t), tlag, tmax,lambdaZ and t1/2 at the times shown above

Interventions:
  • Drug: Lamotrigine IR tablets
  • Drug: Lamotrigine ODT tablets
    • Enrollment:
    220
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    This study has not been published in the scientific literature.
    Medical condition
    Mental Disorders
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    May 2007 to June 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    19 - 55 years
    Accepts healthy volunteers
    Yes
    • Healthy male or female subjects aged 19 to 55 years inclusive
    • BMI within the range 19 to 32 kg/m2 inclusive.
    • Female subjects of childbearing potential will not be eligible if they are unwilling or unable to use an appropriate method of contraception at least 30 days prior to the first study drug through 30 days.
    • Female subject is pregnant or lactating.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy male or female subjects aged 19 to 55 years inclusive
    • BMI within the range 19 to 32 kg/m2 inclusive.
    Exclusion criteria:
    • Female subjects of childbearing potential will not be eligible if they are unwilling or unable to use an appropriate method of contraception at least 30 days prior to the first study drug through 30 days.
    • Female subject is pregnant or lactating.
    • Female subjects using hormonal contraceptive precautions including progesterone-coated intra-uterine device (IUD).
    • Female subjects using hormonal replacement therapy.
    • History of regular alcohol consumption > 7 drinks week for women and 14 drinks week for men
    • Current smokers of 10 or more cigarettes per day

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75247
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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
    2007-19-06

    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

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    Additional information
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