0 Evaluaciones
ID

41302

Descripción

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

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Versiones (1)
  1. 12/8/20 12/8/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

12 de agosto de 2020

DOI

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Licencia

Creative Commons BY 4.0
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    Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

    Inglés

    Laboratory Result Data; Urinalysis

    1 formularios  
    Administrative
    Descripción

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descripción

    Subject Identifier

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Laboratory Result data (Haematology) - 12 Hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
    Descripción

    Laboratory Result data (Haematology) - 12 Hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    UMLS CUI-3
    C0439568
    Date and time sample taken (Haematology)
    Descripción

    Date and time sample taken (Haematology)

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0200345
    UMLS CUI [1,4]
    C0018941
    Has the subject fasted?
    Descripción

    Has the subject fasted?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0015663
    Haematology Test (Treatment Period 1, 2, 3, 4, 5)
    Descripción

    Haematology Test (Treatment Period 1, 2, 3, 4, 5)

    Alias
    UMLS CUI-1
    C0018941
    Haematology Test
    Descripción

    Haematology Test

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0018941
    Haematology Test Result
    Descripción

    Haematology Test Result

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0018941
    UMLS CUI [2]
    C0587081
    Urinalysis - 12 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
    Descripción

    Urinalysis - 12 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C0439568
    Date and time sample taken (Urinalysis)
    Descripción

    Date and time sample taken (Urinalysis)

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0200345
    UMLS CUI [2]
    C0042014
    Urinalysis (Dipstick) Test - 12 hrs (Treatment Period 1, 2, 3, 4, 5)
    Descripción

    Urinalysis (Dipstick) Test - 12 hrs (Treatment Period 1, 2, 3, 4, 5)

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C0430370
    Urinalysis (Dipstick) Test
    Descripción

    Urinalysis (Dipstick) Test

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0430370
    Urinalysis (Dipstick) Test Result
    Descripción

    Urinalysis (Dipstick) Test Result

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0430370
    UMLS CUI [2]
    C0587081
    Urinalysis (Microscopy) Test
    Descripción

    Urinalysis (Microscopy) Test

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0430397
    Urinalysis (Microscopy) Test Result
    Descripción

    Urinalysis (Microscopy) Test Result

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0430397
    UMLS CUI [2]
    C0587081
    Laboratory Result Data (Haematology) - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
    Descripción

    Laboratory Result Data (Haematology) - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0474523
    UMLS CUI-3
    C0439568
    Date and time sample taken (Haematology)
    Descripción

    Date and time sample taken (Haematology)

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0200345
    UMLS CUI [1,4]
    C0018941
    Has the subject fasted?
    Descripción

    Has the subject fasted?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0015663
    Haematology Test - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
    Descripción

    Haematology Test - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)

    Alias
    UMLS CUI-1
    C0018941
    Haematology Test
    Descripción

    Haematology Test

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0018941
    Haematology Test Result
    Descripción

    Haematology Test Result

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0018941
    UMLS CUI [2]
    C0587081
    Urinalysis - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
    Descripción

    Urinalysis - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C0439568
    Date and time sample taken (Urinalysis)
    Descripción

    Date and time sample taken (Urinalysis)

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0200345
    UMLS CUI [2]
    C0042014
    Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5)
    Descripción

    Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5)

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C0430370
    Urinalysis (Dipstick) Test
    Descripción

    Urinalysis (Dipstick) Test

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0430370
    Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5)
    Descripción

    Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5)

    Alias
    UMLS CUI-1
    C0042014
    UMLS CUI-2
    C0430370
    Urinalysis (Dipstick) Test
    Descripción

    Urinalysis (Dipstick) Test

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0430370
    Urinalysis (Dipstick) Test Result
    Descripción

    Urinalysis (Dipstick) Test Result

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0042014
    UMLS CUI [1,2]
    C0430370
    UMLS CUI [2]
    C0587081
    Urinalysis (Microscopy) Test
    Descripción

    Urinalysis (Microscopy) Test

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0430397
    Urinalysis (Microscopy) Test Result
    Descripción

    Urinalysis (Microscopy) Test Result

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0430397
    UMLS CUI [2]
    C0587081
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    Similar models

    Laboratory Result Data; Urinalysis

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Laboratory Result data (Haematology) - 12 Hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    C0439568 (UMLS CUI-3)
    Date and time sample taken (Haematology)
    Item
    Date and time sample taken (Haematology)
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0200345 (UMLS CUI [1,3])
    C0018941 (UMLS CUI [1,4])
    Has the subject fasted?
    Item
    Has the subject fasted?
    boolean
    C0015663 (UMLS CUI [1])
    Item Group
    Haematology Test (Treatment Period 1, 2, 3, 4, 5)
    C0018941 (UMLS CUI-1)
    Item
    Haematology Test
    integer
    C0018941 (UMLS CUI [1])
    Haematology Test
    Code List
    Haematology Test
    CL Item
    Hb (1)
    CL Item
    RBC (2)
    CL Item
    MCV (3)
    CL Item
    MCH (4)
    CL Item
    MCHC (5)
    CL Item
    Haematocrit (6)
    CL Item
    WBC (7)
    CL Item
    Neutrophils (8)
    CL Item
    Lymphocytes (9)
    CL Item
    Monocytes (10)
    CL Item
    Eosinophils (11)
    CL Item
    Basophils (12)
    CL Item
    Platelets (13)
    Haematology Test Result
    Item
    Haematology Test Result
    text
    C0018941 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Item Group
    Urinalysis - 12 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
    C0042014 (UMLS CUI-1)
    C0439568 (UMLS CUI-2)
    Date and time sample taken (Urinalysis)
    Item
    Date and time sample taken (Urinalysis)
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0200345 (UMLS CUI [1,3])
    C0042014 (UMLS CUI [2])
    Item Group
    Urinalysis (Dipstick) Test - 12 hrs (Treatment Period 1, 2, 3, 4, 5)
    C0042014 (UMLS CUI-1)
    C0430370 (UMLS CUI-2)
    Item
    Urinalysis (Dipstick) Test
    integer
    C0042014 (UMLS CUI [1,1])
    C0430370 (UMLS CUI [1,2])
    Urinalysis (Dipstick) Test
    Code List
    Urinalysis (Dipstick) Test
    CL Item
    Protein (1)
    CL Item
    Blood (2)
    CL Item
    Ketones (3)
    CL Item
    Glucose (4)
    CL Item
    Bilirubin (5)
    CL Item
    Urobilinogen (6)
    CL Item
    Leukocyte esterase (7)
    CL Item
    Specific gravity (8)
    CL Item
    Nitrites (9)
    CL Item
    pH (10)
    Urinalysis (Dipstick) Test Result
    Item
    Urinalysis (Dipstick) Test Result
    text
    C0042014 (UMLS CUI [1,1])
    C0430370 (UMLS CUI [1,2])
    C0587081 (UMLS CUI [2])
    Item
    Urinalysis (Microscopy) Test
    integer
    C0430397 (UMLS CUI [1])
    Urinalysis (Microscopy) Test
    Code List
    Urinalysis (Microscopy) Test
    CL Item
    WBC (1)
    CL Item
    RBC (2)
    CL Item
    Hyaline casts (3)
    CL Item
    Granular casts (4)
    CL Item
    Cellular casts (5)
    Urinalysis (Microscopy) Test Result
    Item
    Urinalysis (Microscopy) Test Result
    text
    C0430397 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Item Group
    Laboratory Result Data (Haematology) - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
    C0022885 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    C0439568 (UMLS CUI-3)
    Date and time sample taken (Haematology)
    Item
    Date and time sample taken (Haematology)
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0200345 (UMLS CUI [1,3])
    C0018941 (UMLS CUI [1,4])
    Has the subject fasted?
    Item
    Has the subject fasted?
    boolean
    C0015663 (UMLS CUI [1])
    Item Group
    Haematology Test - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
    C0018941 (UMLS CUI-1)
    Item
    Haematology Test
    integer
    C0018941 (UMLS CUI [1])
    Haematology Test
    Code List
    Haematology Test
    CL Item
    Hb  (1)
    CL Item
    RBC  (2)
    CL Item
    MCV  (3)
    CL Item
    MCH  (4)
    CL Item
    MCHC  (5)
    CL Item
    Haematocrit  (6)
    CL Item
    WBC  (7)
    CL Item
    Neutrophils  (8)
    CL Item
    Lymphocytes  (9)
    CL Item
    Monocytes (10)
    CL Item
    Eosinophils (11)
    CL Item
    Basophils (12)
    CL Item
    Platelets (13)
    Haematology Test Result
    Item
    Haematology Test Result
    text
    C0018941 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
    Item Group
    Urinalysis - 24 hrs Post-Dose (Treatment Period 1, 2, 3, 4, 5)
    C0042014 (UMLS CUI-1)
    C0439568 (UMLS CUI-2)
    Date and time sample taken (Urinalysis)
    Item
    Date and time sample taken (Urinalysis)
    datetime
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0200345 (UMLS CUI [1,3])
    C0042014 (UMLS CUI [2])
    Item Group
    Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5)
    C0042014 (UMLS CUI-1)
    C0430370 (UMLS CUI-2)
    Item
    Urinalysis (Dipstick) Test
    integer
    C0042014 (UMLS CUI [1,1])
    C0430370 (UMLS CUI [1,2])
    Urinalysis (Dipstick) Test
    Code List
    Urinalysis (Dipstick) Test
    CL Item
    Protein  (1)
    CL Item
    Blood  (2)
    CL Item
    Ketones  (3)
    CL Item
    Glucose  (4)
    CL Item
    Bilirubin  (5)
    CL Item
    Urobilinogen  (6)
    CL Item
    Leukocyte esterase  (7)
    CL Item
    Specific gravity  (8)
    CL Item
    Nitrites  (9)
    CL Item
    pH (10)
    Item Group
    Urinalysis (Dipstick) Test - 24 hrs (Treatment Period 1, 2, 3, 4, 5)
    C0042014 (UMLS CUI-1)
    C0430370 (UMLS CUI-2)
    Item
    Urinalysis (Dipstick) Test
    integer
    C0042014 (UMLS CUI [1,1])
    C0430370 (UMLS CUI [1,2])
    Urinalysis (Dipstick) Test
    Code List
    Urinalysis (Dipstick) Test
    CL Item
    Protein  (1)
    CL Item
    Blood  (2)
    CL Item
    Ketones  (3)
    CL Item
    Glucose  (4)
    CL Item
    Bilirubin  (5)
    CL Item
    Urobilinogen  (6)
    CL Item
    Leukocyte esterase  (7)
    CL Item
    Specific gravity  (8)
    CL Item
    Nitrites  (9)
    CL Item
    pH (10)
    Urinalysis (Dipstick) Test Result
    Item
    Urinalysis (Dipstick) Test Result
    text
    C0042014 (UMLS CUI [1,1])
    C0430370 (UMLS CUI [1,2])
    C0587081 (UMLS CUI [2])
    Item
    Urinalysis (Microscopy) Test
    integer
    C0430397 (UMLS CUI [1])
    Urinalysis (Microscopy) Test
    Code List
    Urinalysis (Microscopy) Test
    CL Item
    WBC  (1)
    CL Item
    RBC  (2)
    CL Item
    Hyaline casts  (3)
    CL Item
    Granular casts  (4)
    CL Item
    Cellular casts (5)
    Urinalysis (Microscopy) Test Result
    Item
    Urinalysis (Microscopy) Test Result
    text
    C0430397 (UMLS CUI [1])
    C0587081 (UMLS CUI [2])
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