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ID

36026

Beschreibung

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.

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  1. 09.04.19 09.04.19 -
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GlaxoSmithKline

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9. 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

    Englisch

    Investigator's Check list

    1 Formulare  
    Administrative data
    Beschreibung

    Administrative data

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

    Subject No.

    Datentyp

    text

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

    Panel ID

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    Investigators checklist
    Beschreibung

    Investigators checklist

    Alias
    UMLS CUI-1
    C1707357 (Checklist)
    LOINC
    LP200110-7
    UMLS CUI-2
    C0008961 (Clinical Investigators)
    Check all Adverse Event forms are up to date and complete
    Beschreibung

    Tick when done

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0920316 (Documentation)
    LOINC
    LA17600-0
    UMLS CUI [1,3]
    C0205197 (Complete)
    SNOMED
    255594003
    LOINC
    LA13937-0
    Check that the Concomitant Medication form is up to date
    Beschreibung

    Tick when done

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852 (Concomitant Agent)
    UMLS CUI [1,2]
    C0920316 (Documentation)
    LOINC
    LA17600-0
    UMLS CUI [1,3]
    C0237400 (Actual)
    Check that all appropriate pages are signed (thus indicating completion) and dated
    Beschreibung

    Tick when done

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1283174 (Checking (action))
    SNOMED
    360160009
    LOINC
    LP35034-5
    UMLS CUI [1,2]
    C1519316 (Signature)
    LOINC
    LP248948-4
    Check that laboratory results are included
    Beschreibung

    Tick when done

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1283174 (Checking (action))
    SNOMED
    360160009
    LOINC
    LP35034-5
    UMLS CUI [1,2]
    C1254595 (Laboratory Results)
    UMLS CUI [1,3]
    C0920316 (Documentation)
    LOINC
    LA17600-0
    Signature Principal Investigator
    Beschreibung

    I certify that the observations and findings are recorded correctly and completely in this CRF.

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
    Date of signature
    Beschreibung

    I certify that the observations and findings are recorded correctly and completely in this CRF. day/month/year

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2346576 (Investigator Signature)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
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    Ähnliche Modelle

    Investigator's Check list

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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 Group
    Investigators checklist
    C1707357 (UMLS CUI-1)
    C0008961 (UMLS CUI-2)
    Check Adverse Event forms
    Item
    Check all Adverse Event forms are up to date and complete
    boolean
    C0877248 (UMLS CUI [1,1])
    C0920316 (UMLS CUI [1,2])
    C0205197 (UMLS CUI [1,3])
    Check Concomitant Medication form
    Item
    Check that the Concomitant Medication form is up to date
    boolean
    C2347852 (UMLS CUI [1,1])
    C0920316 (UMLS CUI [1,2])
    C0237400 (UMLS CUI [1,3])
    Check signatures
    Item
    Check that all appropriate pages are signed (thus indicating completion) and dated
    boolean
    C1283174 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    Check laboratory results
    Item
    Check that laboratory results are included
    boolean
    C1283174 (UMLS CUI [1,1])
    C1254595 (UMLS CUI [1,2])
    C0920316 (UMLS CUI [1,3])
    Signature Principal Investigator
    Item
    Signature Principal Investigator
    text
    C2346576 (UMLS CUI [1])
    Date of signature
    Item
    Date of signature
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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