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ID

36030

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. This document contains the vital signs form. It has to be filled in for all Sessions each for both Day 1 and Day 2.

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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

    Vital Signs

    1 forms  
    1. StudyEvent: ODM
      1. Vital Signs
    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
    Visit type
    Description

    Visit type

    Data type

    integer

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

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Vital signs
    Description

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Planned relative time for predose day 1
    Description

    Only for predose day 1.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0518766
    Planned relative time for day 1
    Description

    Only for day 1.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0518766
    Planned relative time for day 2
    Description

    Only for day 2.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0518766
    Date of vital signs
    Description

    day month year

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826644
    Time of vital signs
    Description

    00:00-23:59

    Data type

    time

    Alias
    UMLS CUI [1]
    C2826762
    Systolic Blood pressure
    Description

    Systolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood pressure
    Description

    Diastolic Blood Pressure

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse
    Description

    Pulse

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0232117
    bpm
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    Vital Signs

    1 forms
    1. StudyEvent: ODM
      1. Vital Signs
    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
    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 1 day 2 (2)
    CL Item
    Session 2 day 1  (3)
    CL Item
    Session 2 day 2 (4)
    CL Item
    Session 3 day 1 (5)
    CL Item
    Session 3 day 2 (6)
    CL Item
    Session 4 day 1 (7)
    CL Item
    Session 4 day 2 (8)
    CL Item
    Session 5 day 1 (9)
    CL Item
    Session 5 day 2 (10)
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Item
    Planned relative time for predose day 1
    integer
    C0439564 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Planned relative time for predose day 1
    Code List
    Planned relative time for predose day 1
    CL Item
    Pre/Semi-supine  (1)
    CL Item
    Pre/Standing 1 (2)
    CL Item
    Pre/Semi-supine 2  (3)
    CL Item
    Pre/Standing 2  (4)
    CL Item
    Pre/Semi-supine 3  (5)
    CL Item
    Pre/Standing 3  (6)
    CL Item
    Pre/Semi-supine 4 (7)
    CL Item
    Pre/Standing 4  (8)
    CL Item
    Pre/Semi-supine 5  (9)
    CL Item
    Pre/Standing 5  (10)
    CL Item
    Pre/Semi-supine 6  (11)
    CL Item
    Pre/Standing 6 (12)
    Item
    Planned relative time for day 1
    integer
    C0439564 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Planned relative time for predose day 1
    Code List
    Planned relative time for day 1
    CL Item
    + 1 h/Semi-supine  (1)
    CL Item
    + 1 h/Standing  (2)
    CL Item
    + 2 h/Semi-supine  (3)
    CL Item
    + 2 h/Standing  (4)
    CL Item
    +3 h/Semi-supine  (5)
    CL Item
    +3 h/Standing  (6)
    CL Item
    +4 h/Semi-supine  (7)
    CL Item
    +4 h/Standing  (8)
    CL Item
    +5 h/Semi-supine  (9)
    CL Item
    +5 h/Standing  (10)
    CL Item
    +6 h/Semi-supine  (11)
    CL Item
    +6 h/Standing (12)
    Item
    Planned relative time for day 2
    integer
    C0439564 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Planned relative time for predose day 1
    Code List
    Planned relative time for day 2
    CL Item
    + 16 h/Semi-supine  (1)
    CL Item
    + 16 h/Standing  (2)
    CL Item
    + 24 h/Semi-supine  (3)
    CL Item
    + 24 h/Standing (4)
    Date of vital signs
    Item
    Date of vital signs
    date
    C2826644 (UMLS CUI [1])
    Time of vital signs
    Item
    Time of vital signs
    time
    C2826762 (UMLS CUI [1])
    Systolic Blood Pressure
    Item
    Systolic Blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood pressure
    integer
    C0428883 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
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