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ID

36117

Beskrivning

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Comments and Missing Data form. It can be filled in for the end of study.

Nyckelord

Versioner (1)
  1. 2019-04-15 2019-04-15 -
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GlaxoSmithKline

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15 april 2019

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Creative Commons BY-NC 3.0
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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    Engelsk

    Comments, Missing Data

    1 Formulär  
    1. StudyEvent: ODM
      1. Comments, Missing Data
    Administrative data
    Beskrivning

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Beskrivning

    Subject Number

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Beskrivning

    Panel ID

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3846158
    GSK Receipt Date
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Comments
    Beskrivning

    Comments

    Alias
    UMLS CUI-1
    C0947611
    Visit type
    Beskrivning

    Tick for the itemgroup "Comments"

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Department
    Beskrivning

    Department

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1704729
    Number
    Beskrivning

    Number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0237753
    Comment
    Beskrivning

    Comment

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Date
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Signature
    Beskrivning

    Signature

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C1519316
    Missing Data
    Beskrivning

    Missing Data

    Alias
    UMLS CUI-1
    C1705492
    UMLS CUI-2
    C1511726
    Form
    Beskrivning

    Form

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0348078
    Visit
    Beskrivning

    Visit

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0545082
    Missing Data Point
    Beskrivning

    Missing Data Point

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1705492
    UMLS CUI [1,2]
    C1511726
    Reason
    Beskrivning

    Reason

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0566251
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    Similar models

    Comments, Missing Data

    1 Formulär
    1. StudyEvent: ODM
      1. Comments, Missing Data
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    Date
    Item
    GSK Receipt Date
    date
    C0011008 (UMLS CUI [1])
    Item Group
    Comments
    C0947611 (UMLS CUI-1)
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    Screening (1)
    CL Item
    Session 1 day 1 (2)
    CL Item
    Session 1 day 2 (3)
    CL Item
    Session 2 day 1  (4)
    CL Item
    Session 2 day 2 (5)
    CL Item
    Session 3 day 1 (6)
    CL Item
    Session 3 day 2 (7)
    CL Item
    Session 4 day 1 (8)
    CL Item
    Session 4 day 2 (9)
    CL Item
    Session 5 day 1 (10)
    CL Item
    Session 5 day 2 (11)
    CL Item
    Follow-up (12)
    Department
    Item
    Department
    text
    C1704729 (UMLS CUI [1])
    Number
    Item
    Number
    integer
    C0237753 (UMLS CUI [1])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Signature
    Item
    Signature
    text
    C1519316 (UMLS CUI [1])
    Item Group
    Missing Data
    C1705492 (UMLS CUI-1)
    C1511726 (UMLS CUI-2)
    Form
    Item
    Form
    text
    C0348078 (UMLS CUI [1])
    Item
    Visit
    integer
    C0545082 (UMLS CUI [1])
    Visit
    Code List
    Visit
    CL Item
    Screening (1)
    CL Item
    Session 1 day 1 (2)
    CL Item
    Session 1 day 2 (3)
    CL Item
    Session 2 day 1  (4)
    CL Item
    Session 2 day 2 (5)
    CL Item
    Session 3 day 1 (6)
    CL Item
    Session 3 day 2 (7)
    CL Item
    Session 4 day 1 (8)
    CL Item
    Session 4 day 2 (9)
    CL Item
    Session 5 day 1 (10)
    CL Item
    Session 5 day 2 (11)
    CL Item
    Follow-up (12)
    Missing Data Point
    Item
    Missing Data Point
    text
    C1705492 (UMLS CUI [1,1])
    C1511726 (UMLS CUI [1,2])
    Reason
    Item
    Reason
    text
    C0566251 (UMLS CUI [1])
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