0 Evaluaciones
ID

25706

Descripción

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title:An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation in healthy volunteers 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: Requip Study Indication : Restless Legs Syndrome

Palabras clave

Versiones (4)
  1. 31/8/17 31/8/17 -
  2. 4/9/17 4/9/17 -
  3. 4/9/17 4/9/17 -
  4. 11/9/17 11/9/17 -
Subido en

11 de septiembre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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    visit screening, period 1, 2, 3, 4 & final examination pregnancy PK and tolerability of ropinirole as 5 new formulations 101468/197

    Inglés

    visit screening, period 1, 2, 3, 4 & final examination pregnancy PK and tolerability of ropinirole as 5 new formulations 101468/197

    1 formularios  
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Focus Panel ID
    Descripción

    focus panel

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C3846158
    Patient No
    Descripción

    patient number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Date
    Descripción

    date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0011008
    Number of Visit
    Descripción

    visit number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1549755
    Treatment
    Descripción

    treatment

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0087111
    Initials
    Descripción

    initials

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2986440
    SERUM PREGNANCY TEST
    Descripción

    SERUM PREGNANCY TEST

    Alias
    UMLS CUI-1
    C0430060
    Was a pregnancy test performed?
    Descripción

    pregnancy test

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0032976
    Time
    Descripción

    time of pregnancy test

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0032976
    If "no" above, please specify reason
    Descripción

    If "other", specify.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0884358
    The pregnancy test result was?
    Descripción

    pregnancy test result

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1274040
    Volver a la parte superior de la página

    Similar models

    visit screening, period 1, 2, 3, 4 & final examination pregnancy PK and tolerability of ropinirole as 5 new formulations 101468/197

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    focus panel
    Item
    Focus Panel ID
    integer
    C3846158 (UMLS CUI [1])
    patient number
    Item
    Patient No
    integer
    C1830427 (UMLS CUI [1])
    date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Item
    Number of Visit
    text
    C1549755 (UMLS CUI [1])
    visit number
    Code List
    Number of Visit
    CL Item
    Screening (Screening)
    CL Item
    Period 1/ Day -1 (Period 1/ Day -1)
    CL Item
    Period 2/ Day -1 (Period 2/ Day -1)
    CL Item
    Period 3/ Day -1 (Period 3/ Day -1)
    CL Item
    Period 4/ Day -1 (Period 4/ Day -1)
    CL Item
    Final Examination (Final Examination)
    treatment
    Item
    Treatment
    text
    C0087111 (UMLS CUI [1])
    initials
    Item
    Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    SERUM PREGNANCY TEST
    C0430060 (UMLS CUI-1)
    Item
    Was a pregnancy test performed?
    text
    C0032976 (UMLS CUI [1])
    pregnancy test
    Code List
    Was a pregnancy test performed?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    time of pregnancy test
    Item
    Time
    time
    C0040223 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
    Item
    If "no" above, please specify reason
    text
    C0032976 (UMLS CUI [1,1])
    C0884358 (UMLS CUI [1,2])
    pregnancy test not done
    Code List
    If "no" above, please specify reason
    CL Item
    male (male)
    CL Item
    other (other)
    Item
    The pregnancy test result was?
    text
    C0032976 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    pregnancy test result
    Code List
    The pregnancy test result was?
    CL Item
    Positive (Positive)
    CL Item
    Negative (Negative)
    Volver a la parte superior de la página 

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