0 Bedömningar
ID

36010

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

Nyckelord

Versioner (1)
  1. 2019-04-09 2019-04-09 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

9 april 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

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

    Engelsk

    Plasma Drug Assay

    1 Formulär  
    1. StudyEvent: ODM
      1. Plasma Drug Assay
    Administrative data
    Beskrivning

    Administrative data

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

    Subject No.

    Datatyp

    text

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

    Panel ID

    Datatyp

    text

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

    Visit type

    Datatyp

    integer

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

    Plasma Drug Assay

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

    day month year

    Datatyp

    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
    Beskrivning

    00:00-23:59

    Datatyp

    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
    Beskrivning

    Only tick for Day 1.

    Datatyp

    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
    Beskrivning

    Only tick for Day 2.

    Datatyp

    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
    Beskrivning

    day month year

    Datatyp

    date

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

    00:00-23:59

    Datatyp

    time

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

    Blood samples taken

    Datatyp

    text

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

    Initials

    Datatyp

    text

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

    Comments

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Tillbaka till toppen

    Similar models

    Plasma Drug Assay

    1 Formulär
    1. StudyEvent: ODM
      1. Plasma Drug Assay
    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])
    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])
    Tillbaka till toppen 

    Hjälp

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial