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ID

36094

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

Nyckelord

  1. 2019-04-15 2019-04-15 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 april 2019

DOI

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Licens

Creative Commons BY-NC 3.0

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

    Dosing Details

    1. StudyEvent: ODM
      1. Dosing Details
    Administrative data
    Beskrivning

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Beskrivning

    Subject No.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Beskrivning

    Panel ID

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit type
    Beskrivning

    Visit type

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Visit Date
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Dosing Details
    Beskrivning

    Dosing Details

    Alias
    UMLS CUI-1
    C0013227
    UMLS CUI-2
    C0178602
    Exact time of dosing
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0040223
    Dose checked and administered by
    Beskrivning

    Dose checked and administered by

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1283174
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C2826892
    UMLS CUI [2,1]
    C0806914
    UMLS CUI [2,2]
    C2826892
    Dose checked and witnessed by
    Beskrivning

    Dose checked and witnessed by

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0682356
    UMLS CUI [1,2]
    C1283174
    UMLS CUI [1,3]
    C0178602
    Comments
    Beskrivning

    Comments

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611

    Similar models

    Dosing Details

    1. StudyEvent: ODM
      1. Dosing Details
    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])
    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])

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