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ID

36090

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

Nyckelord

Versioner (2)
  1. 2019-04-15 2019-04-15 -
  2. 2019-04-15 2019-04-15 -
Rättsinnehavare

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

    Engelsk

    Laboratory Collections

    1 Formulär  
    1. StudyEvent: ODM
      1. Laboratory Collections
    Administrative data
    Beskrivning

    Administrative data

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

    Subject No.

    Datatyp

    text

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

    Panel ID

    Datatyp

    text

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

    Visit type

    Datatyp

    integer

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

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    CLINICAL CHEMISTRY and HAEMATOLOGY
    Beskrivning

    CLINICAL CHEMISTRY and HAEMATOLOGY

    Alias
    UMLS CUI-1
    C0008000 (Chemistry, Clinical)
    UMLS CUI-2
    C0018941 (Hematologic Tests)
    SNOMED
    252275004
    Exact time of sampling
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Comments
    Beskrivning

    Comments

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0438215 (Laboratory test result abnormal)
    SNOMED
    165346000
    URINALYSIS
    Beskrivning

    URINALYSIS

    Alias
    UMLS CUI-1
    C0042014 (Urinalysis)
    SNOMED
    167217005
    LOINC
    LP32744-2
    Exact time of sampling
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0178913 (Blood specimen)
    SNOMED
    119297000
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Comments
    Beskrivning

    Comments

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    Beskrivning

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

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0438142 (Urine screening abnormal)
    SNOMED
    167222005
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    Similar models

    Laboratory Collections

    1 Formulär
    1. StudyEvent: ODM
      1. Laboratory Collections
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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
    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])
    Abnormal values
    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])
    Abnormal values
    Code List
    Are there CLINICALLY SIGNIFICANT ABNORMAL values?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Tillbaka till toppen 

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