0 Ratings
ID

36095

Description

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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Versions (1)
  1. 4/15/19 4/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 15, 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

    English

    Predose Meal Recording

    1 forms  
    1. StudyEvent: ODM
      1. Predose Meal Recording
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Description

    Subject No.

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Description

    Panel ID

    Data type

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit type
    Description

    Visit type

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Visit Date
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Meal Recording
    Description

    Meal Recording

    Alias
    UMLS CUI-1
    C1998602
    UMLS CUI-2
    C0034869
    Was the meal eaten before dosing?
    Description

    Meal before dosing

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1998602
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C3469597
    Kind of meal
    Description

    Kind of meal

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1998602
    UMLS CUI [1,2]
    C0332307
    Start time of eating meal
    Description

    00.00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C3842710
    Stop time of eating meal
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C3842710
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
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    Similar models

    Predose Meal Recording

    1 forms
    1. StudyEvent: ODM
      1. Predose Meal Recording
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    Back to the top of the page 

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