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ID

36026

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.

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Versions (1)
  1. 4/9/19 4/9/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 9, 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

    Investigator's Check list

    1 forms  
    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
    Investigators checklist
    Description

    Investigators checklist

    Alias
    UMLS CUI-1
    C1707357
    UMLS CUI-2
    C0008961
    Check all Adverse Event forms are up to date and complete
    Description

    Tick when done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0920316
    UMLS CUI [1,3]
    C0205197
    Check that the Concomitant Medication form is up to date
    Description

    Tick when done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0920316
    UMLS CUI [1,3]
    C0237400
    Check that all appropriate pages are signed (thus indicating completion) and dated
    Description

    Tick when done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1283174
    UMLS CUI [1,2]
    C1519316
    Check that laboratory results are included
    Description

    Tick when done

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1283174
    UMLS CUI [1,2]
    C1254595
    UMLS CUI [1,3]
    C0920316
    Signature Principal Investigator
    Description

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

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Date of signature
    Description

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

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Similar models

    Investigator's Check list

    1 forms
    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 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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