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ID

36095

Beschrijving

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 Predose Meal Recording form. It has to be filled in for all sessions each for day 1.

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Versies (1)
  1. 15-04-19 15-04-19 -
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GlaxoSmithKline

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15 april 2019

DOI

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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

    Engels

    Predose Meal Recording

    1 Formulieren  
    1. StudyEvent: ODM
      1. Predose Meal Recording
    Administrative data
    Beschrijving

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject No.
    Beschrijving

    Subject No.

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Panel ID
    Beschrijving

    Panel ID

    Datatype

    text

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    Visit type
    Beschrijving

    Visit type

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Visit Date
    Beschrijving

    day month year

    Datatype

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Meal Recording
    Beschrijving

    Meal Recording

    Alias
    UMLS CUI-1
    C1998602 (Meal (occasion for eating))
    LOINC
    MTHU051571
    UMLS CUI-2
    C0034869 (Records)
    Was the meal eaten before dosing?
    Beschrijving

    Meal before dosing

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1998602 (Meal (occasion for eating))
    LOINC
    MTHU051571
    UMLS CUI [1,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [1,3]
    C3469597 (Administration of medication)
    SNOMED
    18629005
    Kind of meal
    Beschrijving

    Kind of meal

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C1998602 (Meal (occasion for eating))
    LOINC
    MTHU051571
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Start time of eating meal
    Beschrijving

    00.00-23:59

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    UMLS CUI [1,2]
    C3842710 (Eating a meal)
    LOINC
    LA17899-8
    Stop time of eating meal
    Beschrijving

    00:00-23:59

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C1522314 (End Time)
    SNOMED
    397898000
    UMLS CUI [1,2]
    C3842710 (Eating a meal)
    LOINC
    LA17899-8
    Comments
    Beschrijving

    Comments

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
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    Predose Meal Recording

    1 Formulieren
    1. StudyEvent: ODM
      1. Predose Meal Recording
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (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
    Session 1 day 1 (1)
    CL Item
    Session 2 day 1 (2)
    CL Item
    Session 3 day 1 (3)
    CL Item
    Session 4 day 1 (4)
    CL Item
    Session 5 day 1 (5)
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Meal Recording
    C1998602 (UMLS CUI-1)
    C0034869 (UMLS CUI-2)
    Item
    Was the meal eaten before dosing?
    text
    C1998602 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C3469597 (UMLS CUI [1,3])
    Meal before dosing
    Code List
    Was the meal eaten before dosing?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item
    Kind of meal
    integer
    C1998602 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Kind of meal
    Code List
    Kind of meal
    CL Item
    standardised normal meal (1)
    CL Item
    high fat FDA meal (2)
    Start time
    Item
    Start time of eating meal
    time
    C1301880 (UMLS CUI [1,1])
    C3842710 (UMLS CUI [1,2])
    Stop time
    Item
    Stop time of eating meal
    time
    C1522314 (UMLS CUI [1,1])
    C3842710 (UMLS CUI [1,2])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
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