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36094

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. This document contains the Dosing Details form. It has to be filled in for all sessions each for day 1.

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  1. 15.04.19 15.04.19 -
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GlaxoSmithKline

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15. April 2019

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

    Englisch

    Dosing Details

    1 Formulare  
    1. StudyEvent: ODM
      1. Dosing Details
    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
    Visit type
    Beschreibung

    Visit type

    Datentyp

    integer

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

    day month year

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Dosing Details
    Beschreibung

    Dosing Details

    Alias
    UMLS CUI-1
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI-2
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    Exact time of dosing
    Beschreibung

    00:00-23:59

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Dose checked and administered by
    Beschreibung

    Dose checked and administered by

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1283174 (Checking (action))
    SNOMED
    360160009
    LOINC
    LP35034-5
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,3]
    C2826892 (Investigator Name)
    UMLS CUI [2,1]
    C0806914 (Medication administered)
    LOINC
    MTHU008310
    UMLS CUI [2,2]
    C2826892 (Investigator Name)
    Dose checked and witnessed by
    Beschreibung

    Dose checked and witnessed by

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0682356 (Witnesses)
    UMLS CUI [1,2]
    C1283174 (Checking (action))
    SNOMED
    360160009
    LOINC
    LP35034-5
    UMLS CUI [1,3]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    Comments
    Beschreibung

    Comments

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Dosing Details

    1 Formulare
    1. StudyEvent: ODM
      1. Dosing Details
    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
    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
    Dosing Details
    C0013227 (UMLS CUI-1)
    C0178602 (UMLS CUI-2)
    Exact time of dosing
    Item
    Exact time of dosing
    time
    C0178602 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Dose checked and administered by
    Item
    Dose checked and administered by
    text
    C1283174 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C2826892 (UMLS CUI [1,3])
    C0806914 (UMLS CUI [2,1])
    C2826892 (UMLS CUI [2,2])
    Dose checked and witnessed by
    Item
    Dose checked and witnessed by
    text
    C0682356 (UMLS CUI [1,1])
    C1283174 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Zum Seitenanfang zurückkehren 

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