Last updated: 11/03/2018 11:18:00

Relative Bioavailability study for GSK1838262 (gabapentin enacarbil)

GSK study ID
110882
See study documents
Clinicaltrials.gov ID
NCT00833391
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, single dose, five-period crossover study to evaluate the relative bioavailability of different formulations of GSK1838262 in healthy volunteers.
Trial description: The purpose of this study is to evaluate the relative drug concentrations achieved with different formulations of GSK1838262 in healthy volunteers.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

gabapentin concentrations in blood

Timeframe: measured up to 36 hr after dosing

Secondary outcomes:

Safety and tolerability as measured by adverse events, vital signs, ECGs and clinical laboratory tests.

Timeframe: throughout the study

gabapentin concentrations in urine

Timeframe: measured up to 36 hr after dosing

Interventions:
  • Drug: open label
    • Enrollment:
    16
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Neuropathy, Diabetic
    Product
    gabapentin enacarbil
    Collaborators
    Not applicable
    Study date(s)
    January 2009 to March 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 Year
    Accepts healthy volunteers
    yes
    • healthy, male and female subjects aged between 18 and 65 years old.
    • normal body weight.
    • positive blood alcohol or urine drug test.
    • positive hepatitis B/C and HIV
    Inclusion and exclusion criteria
    Inclusion criteria:
    • healthy, male and female subjects aged between 18 and 65 years old.
    • normal body weight.
    • normal ECG, vital signs and lab tests.
    • normal kidney function
    • agree to use acceptable contraceptive methods required.
    • capable of giving written informed consent.
    Exclusion criteria:
    • positive blood alcohol or urine drug test.
    • positive hepatitis B/C and HIV
    • donation of more than 450 mL blood within the 56 days.
    • sensitivity to gabapentin
    • pregnant or lactating females
    • smoker
    • certain medical conditions including heart disease, psychiatric disease, gastrointestinal disease, kidney or liver dysfunction
    • history of seizure

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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
    2009-12-03

    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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    Access to clinical trial data by researchers
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