0 Evaluaciones
ID

36030

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 vital signs form. It has to be filled in for all Sessions each for both Day 1 and Day 2.

Palabras clave

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

GlaxoSmithKline

Subido en

9 de abril de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

    Sin comentarios

    Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

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

    Inglés

    Vital Signs

    1 formularios  
    1. StudyEvent: ODM
      1. Vital Signs
    Administrative data
    Descripción

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Descripción

    Subject No.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Descripción

    Panel ID

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit type
    Descripción

    Visit type

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Visit Date
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Vital signs
    Descripción

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Planned relative time for predose day 1
    Descripción

    Only for predose day 1.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0518766
    Planned relative time for day 1
    Descripción

    Only for day 1.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0518766
    Planned relative time for day 2
    Descripción

    Only for day 2.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C0518766
    Date of vital signs
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826644
    Time of vital signs
    Descripción

    00:00-23:59

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C2826762
    Systolic Blood pressure
    Descripción

    Systolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic Blood pressure
    Descripción

    Diastolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse
    Descripción

    Pulse

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C0232117
    bpm
    Volver a la parte superior de la página

    Similar models

    Vital Signs

    1 formularios
    1. StudyEvent: ODM
      1. Vital Signs
    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)
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Item
    Planned relative time for predose day 1
    integer
    C0439564 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Planned relative time for predose day 1
    Code List
    Planned relative time for predose day 1
    CL Item
    Pre/Semi-supine  (1)
    CL Item
    Pre/Standing 1 (2)
    CL Item
    Pre/Semi-supine 2  (3)
    CL Item
    Pre/Standing 2  (4)
    CL Item
    Pre/Semi-supine 3  (5)
    CL Item
    Pre/Standing 3  (6)
    CL Item
    Pre/Semi-supine 4 (7)
    CL Item
    Pre/Standing 4  (8)
    CL Item
    Pre/Semi-supine 5  (9)
    CL Item
    Pre/Standing 5  (10)
    CL Item
    Pre/Semi-supine 6  (11)
    CL Item
    Pre/Standing 6 (12)
    Item
    Planned relative time for day 1
    integer
    C0439564 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Planned relative time for predose day 1
    Code List
    Planned relative time for day 1
    CL Item
    + 1 h/Semi-supine  (1)
    CL Item
    + 1 h/Standing  (2)
    CL Item
    + 2 h/Semi-supine  (3)
    CL Item
    + 2 h/Standing  (4)
    CL Item
    +3 h/Semi-supine  (5)
    CL Item
    +3 h/Standing  (6)
    CL Item
    +4 h/Semi-supine  (7)
    CL Item
    +4 h/Standing  (8)
    CL Item
    +5 h/Semi-supine  (9)
    CL Item
    +5 h/Standing  (10)
    CL Item
    +6 h/Semi-supine  (11)
    CL Item
    +6 h/Standing (12)
    Item
    Planned relative time for day 2
    integer
    C0439564 (UMLS CUI [1,1])
    C0518766 (UMLS CUI [1,2])
    Planned relative time for predose day 1
    Code List
    Planned relative time for day 2
    CL Item
    + 16 h/Semi-supine  (1)
    CL Item
    + 16 h/Standing  (2)
    CL Item
    + 24 h/Semi-supine  (3)
    CL Item
    + 24 h/Standing (4)
    Date of vital signs
    Item
    Date of vital signs
    date
    C2826644 (UMLS CUI [1])
    Time of vital signs
    Item
    Time of vital signs
    time
    C2826762 (UMLS CUI [1])
    Systolic Blood Pressure
    Item
    Systolic Blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood pressure
    integer
    C0428883 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Volver a la parte superior de la página 

    Ayuda

    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