0 Evaluaciones
ID

36010

Descripción

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 Plasma Drug Assay fomr. It has to be filled in for all Sessions each for both Day 1 and Day 2.

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Versiones (1)
  1. 9/4/19 9/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

9 de abril de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    Inglés

    Plasma Drug Assay

    1 formularios  
    1. StudyEvent: ODM
      1. Plasma Drug Assay
    Administrative data
    Descripción

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject No.
    Descripción

    Subject No.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Panel ID
    Descripción

    Panel ID

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    Visit type
    Descripción

    Visit type

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0545082 (Visit)
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    Plasma Drug Assay
    Descripción

    Plasma Drug Assay

    Alias
    UMLS CUI-1
    C1609077 (Plasma - SpecimenType)
    LOINC
    LA17760-2
    UMLS CUI-2
    C1261153 (Drug measurement)
    Date of dosing
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Time of dosing
    Descripción

    00:00-23:59

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Time relative to start of dose, Day 1
    Descripción

    Only tick for Day 1.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    Time relative to start of dose, Day 2
    Descripción

    Only tick for Day 2.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    If different from visit date, please note Date of sample
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Actual time
    Descripción

    00:00-23:59

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Blood samples taken for Plasma Assay?
    Descripción

    Blood samples taken

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1277698 (Blood sample taken)
    SNOMED
    313334002
    UMLS CUI [1,2]
    C1609077 (Plasma - SpecimenType)
    LOINC
    LA17760-2
    Initials
    Descripción

    Initials

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Comments
    Descripción

    Comments

    Tipo de datos

    text

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

    Plasma Drug Assay

    1 formularios
    1. StudyEvent: ODM
      1. Plasma Drug Assay
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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)
    Item Group
    Plasma Drug Assay
    C1609077 (UMLS CUI-1)
    C1261153 (UMLS CUI-2)
    Date of dosing
    Item
    Date of dosing
    date
    C0178602 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of dosing
    Item
    Time of dosing
    time
    C0178602 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item
    Time relative to start of dose, Day 1
    integer
    C0439564 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Relative time, Day 1
    Code List
    Time relative to start of dose, Day 1
    CL Item
    +15 min (1)
    CL Item
    +30 min (2)
    CL Item
    +45 min (3)
    CL Item
    +1 h (4)
    CL Item
    +2 h (5)
    CL Item
    +3 h (6)
    CL Item
    +4 h (7)
    CL Item
    +6 h (8)
    Item
    Time relative to start of dose, Day 2
    integer
    C0439564 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Relative time, Day 1
    Code List
    Time relative to start of dose, Day 2
    CL Item
    +8 j (1)
    CL Item
    +10 h (2)
    CL Item
    +12 h (3)
    CL Item
    +14 h (4)
    CL Item
    +16 h (5)
    CL Item
    +24 h (6)
    Sample Date
    Item
    If different from visit date, please note Date of sample
    date
    C1302413 (UMLS CUI [1])
    Actual time
    Item
    Actual time
    time
    C0040223 (UMLS CUI [1])
    Item
    Blood samples taken for Plasma Assay?
    text
    C1277698 (UMLS CUI [1,1])
    C1609077 (UMLS CUI [1,2])
    Blood samples taken
    Code List
    Blood samples taken for Plasma Assay?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Initials
    Item
    Initials
    text
    C2986440 (UMLS CUI [1])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
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