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24026

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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 part: Laboratory Collections

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  1. 2017-07-23 2017-07-23 -
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GlaxoSmithKline

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23 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 Laboratory Collections

    Engelsk

    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Laboratory Collections

    1 Formulär  
    Clinical Chemistry and Haematology
    Beskrivning

    Clinical Chemistry and Haematology

    Alias
    UMLS CUI-1
    C0008000
    UMLS CUI-2
    C0018941
    Exact date an 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 Baseline Signs and Symptoms page.
    Beskrivning

    hematology

    Datatyp

    boolean

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

    Urinanalysis

    Alias
    UMLS CUI-1
    C0042014
    Exact date and time of urine sampling
    Beskrivning

    urine sampling date and time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Comments:
    Beskrivning

    comment

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record on Baseline Signs and Symptoms page.
    Beskrivning

    urinanalysis normal

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0205307
    Drug Screening (Urine)
    Beskrivning

    Drug Screening (Urine)

    Alias
    UMLS CUI-1
    C0202274
    Exact date and time of urine sampling
    Beskrivning

    urine sampling date and time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Were there any contra-indicated drugs detected? If YES, please record all the relevant contra-indicated drugs below.
    Beskrivning

    drug screening positive

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0202274
    UMLS CUI [1,2]
    C1446409
    Type of drug
    Beskrivning

    drug type

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0457591
    Comment
    Beskrivning

    comment

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    HIV and Hepatitis B & C
    Beskrivning

    HIV and Hepatitis B & C

    Alias
    UMLS CUI-1
    C0019682
    UMLS CUI-2
    C0019163
    UMLS CUI-3
    C0019196
    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
    Alcohol Breath Test
    Beskrivning

    Alcohol Breath Test

    Alias
    UMLS CUI-1
    C0202306
    Exact date and time of test
    Beskrivning

    alcohol breath test date and time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0202306
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Alcohol breath test positive or negative? If positive please withdraw from the study.
    Beskrivning

    alcohol breath test

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0202306
    Urine Cotinine Test
    Beskrivning

    Urine Cotinine Test

    Alias
    UMLS CUI-1
    C1697737
    Exact date and time of test
    Beskrivning

    If positive please withdraw from the study.

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C1697737
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Serum b-HCG Pregnancy Test (Females only)
    Beskrivning

    Serum b-HCG Pregnancy Test (Females only)

    Alias
    UMLS CUI-1
    C0430060
    Was a pregnancy test carried out?
    Beskrivning

    pregnancy test

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0430060
    If NO, please specify reason
    Beskrivning

    pregnancy test

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0430060
    If YES, please indicate date and time of test and result: Date and Time of pregnancy test:
    Beskrivning

    pregnancy test date and time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0430060
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    If YES, please indicate date and time of test and result:
    Beskrivning

    If POSITIVE, withdraw the subject from the study.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0430060
    Laboratory name, if applicable
    Beskrivning

    Ensure result is included on laboratory report

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1882331
    Tillbaka till toppen

    Similar models

    GW597599 and paroxetine on the pharmacokinetics of midazolam and dextromethorphan 100716 Laboratory Collections

    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 an 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])
    hematology
    Item
    Are there any CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
    boolean
    C0008000 (UMLS CUI [1,1])
    C0205307 (UMLS CUI [1,2])
    C0018941 (UMLS CUI [2,1])
    C0205307 (UMLS CUI [2,2])
    Item Group
    Urinanalysis
    C0042014 (UMLS CUI-1)
    urine sampling date and time
    Item
    Exact date and time of urine sampling
    datetime
    C0200354 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    comment
    Item
    Comments:
    text
    C0947611 (UMLS CUI [1])
    urinanalysis normal
    Item
    Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record on Baseline Signs and Symptoms page.
    boolean
    C0042014 (UMLS CUI [1,1])
    C0205307 (UMLS CUI [1,2])
    Item Group
    Drug Screening (Urine)
    C0202274 (UMLS CUI-1)
    urine sampling date and time
    Item
    Exact date and time of urine sampling
    datetime
    C0200354 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    drug screening positive
    Item
    Were there any contra-indicated drugs detected? If YES, please record all the relevant contra-indicated drugs below.
    boolean
    C0202274 (UMLS CUI [1,1])
    C1446409 (UMLS CUI [1,2])
    drug type
    Item
    Type of drug
    text
    C0457591 (UMLS CUI [1])
    comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    HIV and Hepatitis B & C
    C0019682 (UMLS CUI-1)
    C0019163 (UMLS CUI-2)
    C0019196 (UMLS CUI-3)
    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])
    Item Group
    Alcohol Breath Test
    C0202306 (UMLS CUI-1)
    alcohol breath test date and time
    Item
    Exact date and time of test
    datetime
    C0202306 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    Alcohol breath test positive or negative? If positive please withdraw from the study.
    text
    C0202306 (UMLS CUI [1])
    alcohol breath test
    Code List
    Alcohol breath test positive or negative? If positive please withdraw from the study.
    CL Item
    Positive (Positive)
    CL Item
    Negative (Negative)
    Item Group
    Urine Cotinine Test
    C1697737 (UMLS CUI-1)
    urine cotinine test date and time
    Item
    Exact date and time of test
    datetime
    C1697737 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item Group
    Serum b-HCG Pregnancy Test (Females only)
    C0430060 (UMLS CUI-1)
    pregnancy test
    Item
    Was a pregnancy test carried out?
    boolean
    C0430060 (UMLS CUI [1])
    pregnancy test
    Item
    If NO, please specify reason
    text
    C0430060 (UMLS CUI [1])
    pregnancy test date and time
    Item
    If YES, please indicate date and time of test and result: Date and Time of pregnancy test:
    datetime
    C0430060 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    If YES, please indicate date and time of test and result:
    text
    C0430060 (UMLS CUI [1])
    alcohol breath test
    Code List
    If YES, please indicate date and time of test and result:
    CL Item
    Positive (Positive)
    CL Item
    Negative (Negative)
    laboratory name
    Item
    Laboratory name, if applicable
    text
    C1882331 (UMLS CUI [1])
    Tillbaka till toppen 

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