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24012

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Study ID: 100716 Clinical Study ID: NKP100716 Study Title: An open label repeat dose study to investigate the effect of GW597599 (15 mg) and paroxetine (10 mg) given in combination for 15 days on the pharmacokinetics of midazolam and dextromethorphan in healthy male and female volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: vestipitant Trade Name: paroxetine and vestipitant Study Indication: Depressive Disorder and Anxiety Disorders Documentation parts: Demography, Medical History and Physical Examination

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Versioner (1)
  1. 2017-07-22 2017-07-22 -
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GlaxoSmithKline

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22 juli 2017

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Creative Commons BY-NC 3.0
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    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Demography, Medical History and Physical Examination

    Engelsk

    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Demography, Medical History and Physical Examination

    1 Formulär  
    Demography
    Beskrivning

    Demography

    Alias
    UMLS CUI-1
    C0011298
    Date of birth
    Beskrivning

    date of birth

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Beskrivning

    gender

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Beskrivning

    race

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0034510
    other race
    Beskrivning

    race

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0034510
    Height
    Beskrivning

    height

    Datatyp

    integer

    Måttenheter
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Beskrivning

    weight

    Datatyp

    float

    Måttenheter
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body Mass Index
    Beskrivning

    bmi

    Datatyp

    float

    Måttenheter
    • kg/m²
    Alias
    UMLS CUI [1]
    C1305855
    kg/m²
    Significant medical/surgical history
    Beskrivning

    Significant medical/surgical history

    Alias
    UMLS CUI-1
    C0262926
    Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
    Beskrivning

    medical condition

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0012634
    Diagnosis
    Beskrivning

    diagnosis

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0011900
    year of first diagnosis
    Beskrivning

    year of first diagnosis

    Datatyp

    text

    Måttenheter
    • Month/Year
    Alias
    UMLS CUI [1,1]
    C0439234
    UMLS CUI [1,2]
    C0011900
    Month/Year
    Past/Ongoing
    Beskrivning

    ongoing disease

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0549178
    UMLS CUI [1,2]
    C0012634
    Physical Examination
    Beskrivning

    Physical Examination

    Alias
    UMLS CUI-1
    C0031809
    Date
    Beskrivning

    physical examination date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2826643
    Time
    Beskrivning

    physical examintation time

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C2826761
    Was the physical examination?
    Beskrivning

    physical examination

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0031809
    Record below:
    Beskrivning

    physical examination

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0031809
    Vital Signs
    Beskrivning

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Study time
    Beskrivning

    study time

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2348563
    UMLS CUI [1,2]
    C0040223
    Date
    Beskrivning

    date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Actual Time
    Beskrivning

    time

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Systolic Blood Pressure
    Beskrivning

    systolic blood pressure

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Beskrivning

    diastolic blood pressure

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart Rate
    Beskrivning

    heart rate

    Datatyp

    integer

    Måttenheter
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    respiratory rate
    Beskrivning

    respiratory rate

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0231832
    12-Lead ECG Monitoring
    Beskrivning

    12-Lead ECG Monitoring

    Alias
    UMLS CUI-1
    C0430456
    Study time
    Beskrivning

    study time

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C2348563
    UMLS CUI [1,2]
    C0040223
    Date
    Beskrivning

    date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Actual time
    Beskrivning

    time

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Heart Rate
    Beskrivning

    heart rate

    Datatyp

    integer

    Måttenheter
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    PR
    Beskrivning

    pr duration

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C1880446
    msec
    QRS
    Beskrivning

    qrs duration

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C1880451
    msec
    QT
    Beskrivning

    qt duration

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C1880452
    msec
    QTC
    Beskrivning

    qtc duration

    Datatyp

    float

    Alias
    UMLS CUI [1]
    C0860814
    ECG normal?
    Beskrivning

    ecg normal

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0522054
    Comments
    Beskrivning

    ecg comment

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0947611
    Tillbaka till toppen

    Similar models

    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Demography, Medical History and Physical Examination

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Demography
    C0011298 (UMLS CUI-1)
    date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    text
    C0079399 (UMLS CUI [1])
    gender
    Code List
    Gender
    CL Item
    Male (Male)
    CL Item
    Female (Female)
    Item
    Race
    text
    C0034510 (UMLS CUI [1])
    race
    Code List
    Race
    CL Item
    American Hispanic (American Hispanic)
    CL Item
    Arabic/North African (Arabic/North African)
    CL Item
    Black (Black)
    CL Item
    East & South East Asia (East & South East Asia)
    CL Item
    Japanese (Japanese)
    CL Item
    South Asia (South Asia)
    CL Item
    White/Caucasian (White/Caucasian)
    CL Item
    Other (Other)
    race
    Item
    other race
    text
    C0034510 (UMLS CUI [1])
    height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    bmi
    Item
    Body Mass Index
    float
    C1305855 (UMLS CUI [1])
    Item Group
    Significant medical/surgical history
    C0262926 (UMLS CUI-1)
    medical condition
    Item
    Is the subject suffering from or has he/she ever suffered from any significant medical or surgical condition?
    boolean
    C0012634 (UMLS CUI [1])
    diagnosis
    Item
    Diagnosis
    text
    C0011900 (UMLS CUI [1])
    year of first diagnosis
    Item
    text
    C0439234 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Item
    Past/Ongoing
    text
    C0549178 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    ongoing disease
    Code List
    Past/Ongoing
    CL Item
    Past (Past)
    CL Item
    Ongoing (Ongoing)
    Item Group
    Physical Examination
    C0031809 (UMLS CUI-1)
    physical examination date
    Item
    Date
    date
    C2826643 (UMLS CUI [1])
    physical examintation time
    Item
    Time
    time
    C2826761 (UMLS CUI [1])
    Item
    Was the physical examination?
    text
    C0031809 (UMLS CUI [1])
    physical examination
    Code List
    Was the physical examination?
    CL Item
    Normal (Normal)
    CL Item
    Abnormal (Abnormal)
    physical examination
    Item
    Record below:
    text
    C0031809 (UMLS CUI [1])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Item
    Study time
    text
    C2348563 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    study time
    Code List
    Study time
    CL Item
    Screening (Screening)
    CL Item
    Unscheduled (Unscheduled)
    date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    systolic blood pressure
    Item
    Systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1])
    diastolic blood pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1])
    heart rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    respiratory rate
    Item
    integer
    C0231832 (UMLS CUI [1])
    Item Group
    12-Lead ECG Monitoring
    C0430456 (UMLS CUI-1)
    Item
    Study time
    text
    C2348563 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    study time
    Code List
    Study time
    CL Item
    Screening (Screening)
    CL Item
    Unscheduled (Unscheduled)
    date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    heart rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    pr duration
    Item
    PR
    float
    C1880446 (UMLS CUI [1])
    qrs duration
    Item
    QRS
    float
    C1880451 (UMLS CUI [1])
    qt duration
    Item
    QT
    float
    C1880452 (UMLS CUI [1])
    qtc duration
    Item
    QTC
    float
    C0860814 (UMLS CUI [1])
    ecg normal
    Item
    ECG normal?
    boolean
    C0522054 (UMLS CUI [1])
    ecg comment
    Item
    Comments
    text
    C1623258 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Tillbaka till toppen 

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