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ID

24323

Beskrivning

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 Laboratory Collections 2, Dosing Details 2-3

Nyckelord

Versioner (1)
  1. 2017-07-29 2017-07-29 -
Rättsinnehavare

GlaxoSmithKline

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29 juli 2017

DOI

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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 Treatment Period 2 Laboratory Collections 2, Dosing Details 2-3

    Engelsk

    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Laboratory Collections 2, Dosing Details

    1 Formulär  
    Clinical Chemistry And Haematology
    Beskrivning

    Clinical Chemistry And Haematology

    Alias
    UMLS CUI-1
    C0008000
    UMLS CUI-2
    C0018941
    Exact date and time of blood sampling
    Beskrivning

    blood sampling date and time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Comments:
    Beskrivning

    comment

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Are there any CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
    Beskrivning

    clinical chemistry and hematology normal

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0205307
    UMLS CUI [2,1]
    C0018941
    UMLS CUI [2,2]
    C0205307
    PK Sampling
    Beskrivning

    PK Sampling

    Alias
    UMLS CUI-1
    C0031327
    Time relative to start of dose
    Beskrivning

    time since dose

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0946444
    Date
    Beskrivning

    pharmacokinetics date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0011008
    Actual Time
    Beskrivning

    pharmacokinetics time

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0040223
    Sample Taken
    Beskrivning

    blood sample

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    Comments
    Beskrivning

    pharmacokinetics comment

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0031328
    Dosing Details
    Beskrivning

    Dosing Details

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0178602
    Date and time of dosing GW597599
    Beskrivning

    dosing date and time

    Datatyp

    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:
    Beskrivning

    dose administered

    Datatyp

    text

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

    dose witnessed

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0682356
    Tillbaka till toppen

    Similar models

    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Treatment Period 2 Laboratory Collections 2, Dosing Details

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Clinical Chemistry And Haematology
    C0008000 (UMLS CUI-1)
    C0018941 (UMLS CUI-2)
    blood sampling date and time
    Item
    Exact date and time of blood sampling
    datetime
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    comment
    Item
    Comments:
    text
    C0947611 (UMLS CUI [1])
    clinical chemistry and hematology normal
    Item
    Are there any CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on the Adverse Events page.
    boolean
    C0008000 (UMLS CUI [1,1])
    C0205307 (UMLS CUI [1,2])
    C0018941 (UMLS CUI [2,1])
    C0205307 (UMLS CUI [2,2])
    Item Group
    PK Sampling
    C0031327 (UMLS CUI-1)
    Item
    Time relative to start of dose
    text
    C0946444 (UMLS CUI [1])
    time since dose
    Code List
    Time relative to start of dose
    CL Item
    Pre-dose (Pre-dose)
    CL Item
    +1 hr (+1 hr)
    CL Item
    +2 hrs (+2 hrs)
    CL Item
    +3 hrs (+3 hrs)
    CL Item
    +8 hrs (+8 hrs)
    CL Item
    +12 hrs (+12 hrs)
    CL Item
    +24 hrs (+24 hrs)
    CL Item
    +5 hrs (+5 hrs)
    CL Item
    +16 hrs (+16 hrs)
    pharmacokinetics date
    Item
    Date
    date
    C0031328 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    pharmacokinetics time
    Item
    Actual Time
    time
    C0031328 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    blood sample
    Item
    Sample Taken
    boolean
    C0005834 (UMLS CUI [1])
    pharmacokinetics comment
    Item
    Comments
    text
    C0031328 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    Item Group
    Dosing Details
    C0013227 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    dosing date and time
    Item
    Date and time of dosing GW597599
    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])
    Tillbaka till toppen 

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