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ID

43569

Description

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title:An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation in healthy volunteers 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: Requip Study Indication : Restless Legs Syndrome

Keywords

Versions (3)
  1. 9/11/17 9/11/17 -
  2. 9/12/17 9/12/17 -
  3. 9/20/21 9/20/21 -
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September 20, 2021

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Creative Commons BY-NC 3.0
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    visit period 1,2,3 & 4 plasma drug assay PK and tolerability of ropinirole as 5 new formulations 101468/197

    English

    visit period 1,2,3 & 4 plasma drug assay PK and tolerability of ropinirole as 5 new formulations 101468/197

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Focus Panel ID
    Description

    focus panel

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3846158
    Patient No
    Description

    patient number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Date
    Description

    date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Number of Visit
    Description

    visit number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1549755
    Treatment
    Description

    treatment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0087111
    Date and Time
    Description

    Date and Time

    Alias
    UMLS CUI-1
    C1264639
    Actual date and time of dose
    Description

    date and time of dose

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    UMLS CUI [2]
    C3469597
    plasma assay sample
    Description

    plasma assay sample

    Alias
    UMLS CUI-1
    C0444263
    UMLS CUI-3
    C0013227
    UMLS CUI-4
    C0683150
    Time relative to dosing
    Description

    time relative to dosing

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C3469597
    UMLS CUI [1,3]
    C0304229
    Date
    Description

    date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Time
    Description

    time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223
    Comment
    Description

    comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Initials
    Description

    initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440
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    Similar models

    visit period 1,2,3 & 4 plasma drug assay PK and tolerability of ropinirole as 5 new formulations 101468/197

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    focus panel
    Item
    Focus Panel ID
    integer
    C3846158 (UMLS CUI [1])
    patient number
    Item
    Patient No
    integer
    C1830427 (UMLS CUI [1])
    date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Item
    Number of Visit
    text
    C1549755 (UMLS CUI [1])
    visit number
    Code List
    Number of Visit
    CL Item
    Period 1 Day 1-2 (Period 1 Day 1-2)
    CL Item
    Period 2 Day 1-2 (Period 2 Day 1-2)
    CL Item
    Period 3 Day 1-2 (Period 3 Day 1-2)
    CL Item
    Period 4 Day 1-2 (Period 4 Day 1-2)
    treatment
    Item
    Treatment
    text
    C0087111 (UMLS CUI [1])
    Item Group
    Date and Time
    C1264639 (UMLS CUI-1)
    date and time of dose
    Item
    Actual date and time of dose
    datetime
    C1264639 (UMLS CUI [1])
    C3469597 (UMLS CUI [2])
    Item Group
    plasma assay sample
    C0444263 (UMLS CUI-1)
    C0013227 (UMLS CUI-3)
    C0683150 (UMLS CUI-4)
    Item
    Time relative to dosing
    text
    C0439564 (UMLS CUI [1,1])
    C3469597 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    time relative to dosing
    Code List
    Time relative to dosing
    CL Item
    +0:15h (+0:15h)
    CL Item
    +0:30h (+0:30h)
    CL Item
    +0:45h (+0:45h)
    CL Item
    +1:00h (+ 1:00h)
    CL Item
    +2:00h (+ 2:00h)
    CL Item
    +3:00h (+ 3:00h)
    CL Item
    +4:00h (+ 4:00h)
    CL Item
    +6:00h (+ 6:00h)
    CL Item
    +8:00h (+ 8:00h)
    CL Item
    +10:00h (+ 10:00h)
    CL Item
    +12:00h (+ 12:00h)
    CL Item
    +14:00h (+ 14:00h)
    CL Item
    +16:00h (+ 16:00h)
    CL Item
    +18:00h (+ 18:00h)
    CL Item
    +20:00h (+ 20:00h)
    CL Item
    +22:00h (+ 22:00h)
    CL Item
    +24:00h (+ 24:00h)
    CL Item
    +28:00h (+ 28:00h)
    CL Item
    +32:00h (+ 32:00h)
    CL Item
    +36:00h (+ 36:00h)
    date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    time
    Item
    Time
    time
    C0040223 (UMLS CUI [1])
    comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    initials
    Item
    Initials
    text
    C2986440 (UMLS CUI [1])
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