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ID

24287

Description

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 part: Treatment Period 2 Dosing Details 1, Vital Signs 1, 12-Lead ECG Monitoring 1

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  1. 7/28/17 7/28/17 -
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GlaxoSmithKline

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July 28, 2017

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    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details 1, Vital Signs 1, 12-Lead ECG Monitoring 1

    English

    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details, Vital Signs, 12-Lead ECG Monitoring

    1 forms  
    Dosing Details
    Description

    Dosing Details

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0178602
    Date and time of dosing dextrometorphan
    Description

    GW597599 dosing date and time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Dose checked and administered by:
    Description

    dose administered

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348343
    Dose checked and witnessed by:
    Description

    dose witnessed

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0682356
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Study Time
    Description

    study time

    Data type

    text

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

    vital signs date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826644
    Actual Time
    Description

    vital signs time

    Data type

    time

    Alias
    UMLS CUI [1]
    C2826762
    Systolic Blood Pressure
    Description

    systolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Description

    diastolic blood pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    HR
    Description

    heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    12-Lead ECG Monitoring
    Description

    12-Lead ECG Monitoring

    Alias
    UMLS CUI-1
    C0430456
    Study Time
    Description

    study time

    Data type

    text

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

    ecg date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0011008
    Actual Time
    Description

    ecg time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0040223
    Heart Rate
    Description

    heart rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    PR
    Description

    pr interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    QRS
    Description

    qrs duration

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    QT
    Description

    qt duration

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1880452
    msec
    QTC
    Description

    qtc interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0855331
    msec
    ECG normal?
    Description

    ecg normal

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0522054
    Comments
    Description

    ecg comment

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0947611
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    Similar models

    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Dosing Details, Vital Signs, 12-Lead ECG Monitoring

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Dosing Details
    C0013227 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    GW597599 dosing date and time
    Item
    Date and time of dosing dextrometorphan
    datetime
    C0013227 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    dose administered
    Item
    Dose checked and administered by:
    text
    C2348343 (UMLS CUI [1])
    dose witnessed
    Item
    Dose checked and witnessed by:
    text
    C0013227 (UMLS CUI [1,1])
    C0682356 (UMLS CUI [1,2])
    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
    Pre-dose (Pre-dose)
    CL Item
    +0.5 hrs (+0.5 hrs)
    CL Item
    +1 hrs (+1 hrs)
    CL Item
    +4 hrs (+4 hrs)
    CL Item
    +12 hrs (+12 hrs)
    CL Item
    +24 hrs (+24 hrs)
    CL Item
    Unscheduled (Unscheduled)
    vital signs date
    Item
    Date
    date
    C2826644 (UMLS CUI [1])
    vital signs time
    Item
    Actual Time
    time
    C2826762 (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
    HR
    integer
    C0018810 (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
    Pre-dose (Pre-dose)
    CL Item
    +0.5 hrs (+0.5 hrs)
    CL Item
    +1 hrs (+1 hrs)
    CL Item
    +4 hrs (+4 hrs)
    CL Item
    +12 hrs (+12 hrs)
    CL Item
    +24 hrs (+24 hrs)
    CL Item
    Unscheduled (Unscheduled)
    ecg date
    Item
    Date
    date
    C0013798 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    ecg time
    Item
    Actual Time
    time
    C0013798 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    heart rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    pr interval
    Item
    PR
    float
    C0429087 (UMLS CUI [1])
    qrs duration
    Item
    QRS
    float
    C0429025 (UMLS CUI [1])
    qt duration
    Item
    QT
    float
    C1880452 (UMLS CUI [1])
    qtc interval
    Item
    QTC
    float
    C0855331 (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])
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