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ID

36906

Beskrivning

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Pharmacokinetic sampling form. It has to befilled in for Day 1, Day 6, Day 12 and Day 19.

Nyckelord

Versioner (2)
  1. 2017-09-02 2017-09-02 -
  2. 2019-06-21 2019-06-21 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

21 juni 2019

DOI

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Creative Commons BY-NC 3.0
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    Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

    Engelsk

    PK Sampling

    1 Formulär  
    1. StudyEvent: ODM
      1. PK Sampling
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject number
    Beskrivning

    Subject number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Study Week
    Beskrivning

    Study Week

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0008972 (Clinical Research)
    UMLS CUI [1,2]
    C0439230 (week)
    SNOMED
    258705008
    Study Day
    Beskrivning

    Study Day

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2826182 (Study Day)
    PK SAMPLING
    Beskrivning

    PK SAMPLING

    Alias
    UMLS CUI-1
    C0022877 (Laboratory)
    SNOMED
    261904005
    LOINC
    MTHU029808
    Time relative to start of dose
    Beskrivning

    Time relative to start of dose

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    UMLS CUI [1,3]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    Date
    Beskrivning

    day month year The date has to be filled in for Pre-dose, +8 hrs and +10 hrs. If required you can also fill in the date for the other times.

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0808070 (Start Date)
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    Actual time
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Sample taken
    Beskrivning

    Sample taken

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    Comments
    Beskrivning

    Comments

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
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    Similar models

    PK Sampling

    1 Formulär
    1. StudyEvent: ODM
      1. PK Sampling
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item
    Study Week
    integer
    C0008972 (UMLS CUI [1,1])
    C0439230 (UMLS CUI [1,2])
    Study Week
    Code List
    Study Week
    CL Item
    Week 1 (1)
    CL Item
    Week 2 (2)
    CL Item
    Week 3 (3)
    Item
    Study Day
    integer
    C2826182 (UMLS CUI [1])
    Study Day
    Code List
    Study Day
    CL Item
    Day 1 (1)
    CL Item
    Day 6 (2)
    CL Item
    Day 12 (3)
    CL Item
    Day 19 (4)
    Item Group
    PK SAMPLING
    C0022877 (UMLS CUI-1)
    Item
    Time relative to start of dose
    integer
    C0439564 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    Time relative to start of dose
    Code List
    Time relative to start of dose
    CL Item
    Pre-dose (1)
    CL Item
    +0,25 hr (2)
    CL Item
    +0,5 hr (3)
    CL Item
    +0,75 hr (4)
    CL Item
    +1 hr (5)
    CL Item
    +2 hrs (6)
    CL Item
    +3 hrs (7)
    CL Item
    +4 hrs (8)
    CL Item
    +6 hrs (9)
    CL Item
    +8 hrs (10)
    CL Item
    +10 hrs (11)
    CL Item
    +12 hrs (12)
    CL Item
    +14 hrs (13)
    CL Item
    +16 hrs (14)
    CL Item
    +24 hrs (15)
    Date of start dose
    Item
    Date
    date
    C0808070 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Item
    Sample taken
    text
    C0200345 (UMLS CUI [1])
    Sample taken
    Code List
    Sample taken
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
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