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36010

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 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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Versions (1)
  1. 09/04/2019 09/04/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

9 avril 2019

DOI

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Licence

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

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    Plasma Drug Assay

    1 Formulaires  
    1. StudyEvent: ODM
      1. Plasma Drug Assay
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Description

    Subject No.

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Description

    Panel ID

    Type de données

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit type
    Description

    Visit type

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Plasma Drug Assay
    Description

    Plasma Drug Assay

    Alias
    UMLS CUI-1
    C1609077
    UMLS CUI-2
    C1261153
    Date of dosing
    Description

    day month year

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0011008
    Time of dosing
    Description

    00:00-23:59

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0040223
    Time relative to start of dose, Day 1
    Description

    Only tick for Day 1.

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0178602
    Time relative to start of dose, Day 2
    Description

    Only tick for Day 2.

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0178602
    If different from visit date, please note Date of sample
    Description

    day month year

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual time
    Description

    00:00-23:59

    Type de données

    time

    Alias
    UMLS CUI [1]
    C0040223
    Blood samples taken for Plasma Assay?
    Description

    Blood samples taken

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C1609077
    Initials
    Description

    Initials

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2986440
    Comments
    Description

    Comments

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0947611
    Retour au début de la page

    Similar models

    Plasma Drug Assay

    1 Formulaires
    1. StudyEvent: ODM
      1. Plasma Drug Assay
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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