ID

41632

Descripción

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Palabras clave

Versiones (2)
  1. 11/11/20 11/11/20 -
  2. 29/11/20 29/11/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

29 de noviembre de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
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.

    Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692

    Inglés

    Day 1 - 5: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection (Simvastatin)

    1 formularios  
    Administrative
    Descripción

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Site
    Descripción

    Site

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2825164
    Subject
    Descripción

    Subject

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Status
    Descripción

    Status

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0449438
    Doc#
    Descripción

    Doc#

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1301746
    Is Page Blank?
    Descripción

    Is Page Blank?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1704732
    UMLS CUI [1,2]
    C0750479
    Visit Date
    Descripción

    Visit Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Vital Signs (sitting) - Day 1 - 5
    Descripción

    Vital Signs (sitting) - Day 1 - 5

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0277814
    Vital Signs Date
    Descripción

    Vital Signs Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2826644
    Vital Signs Time
    Descripción

    Vital Signs Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C2826762
    Systolic Blood Pressure
    Descripción

    Systolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic Blood Pressure
    Descripción

    Diastolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Temperature
    Descripción

    Temperature

    Tipo de datos

    float

    Unidades de medida
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Heart Rate
    Descripción

    Heart Rate

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Comment
    Descripción

    Comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0947611
    Study Drug Administration (80 mg Simvastatin) - Day 1
    Descripción

    Study Drug Administration (80 mg Simvastatin) - Day 1

    Alias
    UMLS CUI-1
    C0013153
    UMLS CUI-2
    C0074554
    Was the dose administered?
    Descripción

    Was the dose administered?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3174092
    UMLS CUI [2]
    C3469597
    Dose Date
    Descripción

    Dose Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0178602
    UMLS CUI [2]
    C0011008
    Dose Time
    Descripción

    Dose Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0040223
    Comment
    Descripción

    Comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0947611
    Pharmacokinetic Blood Collection (Simvastatin) - Day 1
    Descripción

    Pharmacokinetic Blood Collection (Simvastatin) - Day 1

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005834
    UMLS CUI-3
    C0074554
    Timepoint
    Descripción

    Timepoint

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348792
    Sample Date
    Descripción

    Sample Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1302413
    Sample Time
    Descripción

    Sample Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    Not Done/ Not Collected
    Descripción

    Not Done/ Not Collected

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1272696
    UMLS CUI [2]
    C0445106
    Comment
    Descripción

    Comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0947611
    Pharmacokinetic Blood Collection (Simvastatin) - Day 2
    Descripción

    Pharmacokinetic Blood Collection (Simvastatin) - Day 2

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005834
    UMLS CUI-3
    C0074554
    Timepoint
    Descripción

    Timepoint

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348792
    Sample Date
    Descripción

    Sample Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1302413
    Sample Time
    Descripción

    Sample Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    Not Done/ Not Collected
    Descripción

    Not Done/ Not Collected

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1272696
    UMLS CUI [2]
    C0445106
    Comment
    Descripción

    Comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0947611
    Pharmacokinetic Blood Collection (Simvastatin) - Day 3
    Descripción

    Pharmacokinetic Blood Collection (Simvastatin) - Day 3

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005834
    UMLS CUI-3
    C0074554
    Timepoint
    Descripción

    Timepoint

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348792
    Sample Date
    Descripción

    Sample Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1302413
    Sample Time
    Descripción

    Sample Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    Not Done/ Not Collected
    Descripción

    Not Done/ Not Collected

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1272696
    UMLS CUI [2]
    C0445106
    Comment
    Descripción

    Comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0947611
    Pharmacokinetic Blood Collection (Simvastatin) - Day 4
    Descripción

    Pharmacokinetic Blood Collection (Simvastatin) - Day 4

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005834
    UMLS CUI-3
    C0074554
    Timepoint
    Descripción

    Timepoint

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348792
    Sample Date
    Descripción

    Sample Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1302413
    Sample Time
    Descripción

    Sample Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    Not Done/ Not Collected
    Descripción

    Not Done/ Not Collected

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1272696
    UMLS CUI [2]
    C0445106
    Comment
    Descripción

    Comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0947611
    Pharmacokinetic Blood Collection (Simvastatin) - Day 5
    Descripción

    Pharmacokinetic Blood Collection (Simvastatin) - Day 5

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005834
    UMLS CUI-3
    C0074554
    Timepoint
    Descripción

    Timepoint

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348792
    Sample Date
    Descripción

    Sample Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1302413
    Sample Time
    Descripción

    Sample Time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    Not Done/ Not Collected
    Descripción

    Not Done/ Not Collected

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1272696
    UMLS CUI [2]
    C0445106
    Comment
    Descripción

    Comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0947611
    Volver a la parte superior de la página

    Similar models

    Day 1 - 5: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection (Simvastatin)

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Site
    Item
    Site
    text
    C2825164 (UMLS CUI [1])
    Subject
    Item
    Subject
    text
    C2348585 (UMLS CUI [1])
    Status
    Item
    Status
    text
    C0449438 (UMLS CUI [1])
    Doc#
    Item
    Doc#
    integer
    C1301746 (UMLS CUI [1])
    Is Page Blank?
    Item
    Is Page Blank?
    boolean
    C1704732 (UMLS CUI [1,1])
    C0750479 (UMLS CUI [1,2])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Vital Signs (sitting) - Day 1 - 5
    C0518766 (UMLS CUI-1)
    C0277814 (UMLS CUI-2)
    Vital Signs Date
    Item
    Vital Signs Date
    date
    C2826644 (UMLS CUI [1])
    Vital Signs Time
    Item
    Vital Signs Time
    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])
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Study Drug Administration (80 mg Simvastatin) - Day 1
    C0013153 (UMLS CUI-1)
    C0074554 (UMLS CUI-2)
    Was the dose administered?
    Item
    Was the dose administered?
    boolean
    C3174092 (UMLS CUI [1])
    C3469597 (UMLS CUI [2])
    Dose Date
    Item
    Dose Date
    date
    C0178602 (UMLS CUI [1])
    C0011008 (UMLS CUI [2])
    Dose Time
    Item
    Dose Time
    time
    C0178602 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Pharmacokinetic Blood Collection (Simvastatin) - Day 1
    C0031328 (UMLS CUI-1)
    C0005834 (UMLS CUI-2)
    C0074554 (UMLS CUI-3)
    Item
    Timepoint
    integer
    C2348792 (UMLS CUI [1])
    Timepoint
    Code List
    Timepoint
    CL Item
    Predose (1)
    CL Item
    0.25 hr (2)
    CL Item
    0.5 hr (3)
    CL Item
    1 hr (4)
    CL Item
    1.5 hr (5)
    CL Item
    2 hr (6)
    CL Item
    2.5 hr (7)
    CL Item
    3 hr (8)
    CL Item
    4 hr (9)
    CL Item
    5 hr (10)
    CL Item
    6 hr (11)
    CL Item
    8 hr (12)
    CL Item
    10 hr (13)
    CL Item
    12 hr (14)
    Sample Date
    Item
    Sample Date
    date
    C1302413 (UMLS CUI [1])
    Sample Time
    Item
    Sample Time
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Item
    Not Done/ Not Collected
    integer
    C1272696 (UMLS CUI [1])
    C0445106 (UMLS CUI [2])
    Not Done/ Not Collected
    Code List
    Not Done/ Not Collected
    CL Item
    Not Done/ Not Collected (1)
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Pharmacokinetic Blood Collection (Simvastatin) - Day 2
    C0031328 (UMLS CUI-1)
    C0005834 (UMLS CUI-2)
    C0074554 (UMLS CUI-3)
    Item
    Timepoint
    integer
    C2348792 (UMLS CUI [1])
    Timepoint
    Code List
    Timepoint
    CL Item
    24 hr (1)
    Sample Date
    Item
    Sample Date
    date
    C1302413 (UMLS CUI [1])
    Sample Time
    Item
    Sample Time
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Item
    Not Done/ Not Collected
    integer
    C1272696 (UMLS CUI [1])
    C0445106 (UMLS CUI [2])
    Not Done/ Not Collected
    Code List
    Not Done/ Not Collected
    CL Item
    Not Done/ Not Collected (1)
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Pharmacokinetic Blood Collection (Simvastatin) - Day 3
    C0031328 (UMLS CUI-1)
    C0005834 (UMLS CUI-2)
    C0074554 (UMLS CUI-3)
    Item
    Timepoint
    integer
    C2348792 (UMLS CUI [1])
    Timepoint
    Code List
    Timepoint
    CL Item
    48 hr (1)
    Sample Date
    Item
    Sample Date
    date
    C1302413 (UMLS CUI [1])
    Sample Time
    Item
    Sample Time
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Item
    Not Done/ Not Collected
    integer
    C1272696 (UMLS CUI [1])
    C0445106 (UMLS CUI [2])
    Not Done/ Not Collected
    Code List
    Not Done/ Not Collected
    CL Item
    Not Done/ Not Collected (1)
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Pharmacokinetic Blood Collection (Simvastatin) - Day 4
    C0031328 (UMLS CUI-1)
    C0005834 (UMLS CUI-2)
    C0074554 (UMLS CUI-3)
    Item
    Timepoint
    integer
    C2348792 (UMLS CUI [1])
    Timepoint
    Code List
    Timepoint
    CL Item
    72 hr (1)
    Sample Date
    Item
    Sample Date
    date
    C1302413 (UMLS CUI [1])
    Sample Time
    Item
    Sample Time
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Item
    Not Done/ Not Collected
    integer
    C1272696 (UMLS CUI [1])
    C0445106 (UMLS CUI [2])
    Not Done/ Not Collected
    Code List
    Not Done/ Not Collected
    CL Item
    Not Done/ Not Collected (1)
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Pharmacokinetic Blood Collection (Simvastatin) - Day 5
    C0031328 (UMLS CUI-1)
    C0005834 (UMLS CUI-2)
    C0074554 (UMLS CUI-3)
    Item
    Timepoint
    integer
    C2348792 (UMLS CUI [1])
    Timepoint
    Code List
    Timepoint
    CL Item
    96 hr (1)
    Sample Date
    Item
    Sample Date
    date
    C1302413 (UMLS CUI [1])
    Sample Time
    Item
    Sample Time
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    Item
    Not Done/ Not Collected
    integer
    C1272696 (UMLS CUI [1])
    C0445106 (UMLS CUI [2])
    Not Done/ Not Collected
    Code List
    Not Done/ Not Collected
    CL Item
    Not Done/ Not Collected (1)
    Comment
    Item
    Comment
    text
    C0947611 (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