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ID

36090

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 Laboratory Collections form. It has to be filled in for screening and Follow-up.

Keywords

  1. 4/15/19 4/15/19 -
  2. 4/15/19 4/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 15, 2019

DOI

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License

Creative Commons BY-NC 3.0

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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    Laboratory Collections

    1. StudyEvent: ODM
      1. Laboratory Collections
    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
    CLINICAL CHEMISTRY and HAEMATOLOGY
    Description

    CLINICAL CHEMISTRY and HAEMATOLOGY

    Alias
    UMLS CUI-1
    C0008000
    UMLS CUI-2
    C0018941
    Exact time of sampling
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0178913
    UMLS CUI [1,2]
    C0040223
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    Description

    If YES, please record diagnosis on Baseline Signs and Symptoms page.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0438215
    URINALYSIS
    Description

    URINALYSIS

    Alias
    UMLS CUI-1
    C0042014
    Exact time of sampling
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0178913
    UMLS CUI [1,2]
    C0040223
    Comments
    Description

    Comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    Description

    If YES, please record diagnosis on Baseline Signs and Symptoms page.

    Data type

    text

    Alias
    UMLS CUI [1]
    C0438142

    Similar models

    Laboratory Collections

    1. StudyEvent: ODM
      1. Laboratory Collections
    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])
    Code List
    Visit type
    CL Item
    screening (1)
    CL Item
    follow-up (2)
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    CLINICAL CHEMISTRY and HAEMATOLOGY
    C0008000 (UMLS CUI-1)
    C0018941 (UMLS CUI-2)
    Time of sampling
    Item
    Exact time of sampling
    time
    C0178913 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Item
    Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    text
    C0438215 (UMLS CUI [1])
    Code List
    Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Item Group
    URINALYSIS
    C0042014 (UMLS CUI-1)
    Time of sampling
    Item
    Exact time of sampling
    time
    C0178913 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Item
    Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    text
    C0438142 (UMLS CUI [1])
    Code List
    Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    CL Item
    Yes (Y)
    CL Item
    No (N)

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