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ID

38820

Beskrivning

Study ID: 111610 Clinical Study ID: 111610 Study Title: A randomised, double-blind, placebo-controlled study in healthy volunteers to examine the safety, tolerability and pharmacokinetics of a) single, ascending and b) twice-daily repeat doses of intranasal SB-705498. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00907933 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB705498, Placebo Study Indication: Rhinitis

Nyckelord

Versioner (1)
  1. 2019-11-06 2019-11-06 -
Rättsinnehavare

GlaxoSmithKline

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6 november 2019

DOI

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Creative Commons BY-NC 3.0
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    Safety, tolerability and pharmacokinetics of single, ascending and twice-daily repeat doses of intranasal SB-705498 NCT00907933

    Engelsk

    Pharmacokinetics Blood (Period 1 - 5; Day 1 - Day 16)

    1 Formulär  
    Pharmacokinetics Blood - Dosing date and time (Period 1 - 5)
    Beskrivning

    Pharmacokinetics Blood - Dosing date and time (Period 1 - 5)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    UMLS CUI-3
    C0178602
    UMLS CUI-4
    C1264639
    Dosing date and time
    Beskrivning

    Dosing date and time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C1264639
    Repeat Pharmacokinetics Blood (Period 1 - 5)
    Beskrivning

    Repeat Pharmacokinetics Blood (Period 1 - 5)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    UMLS CUI-3
    C0205341
    Actual date/time
    Beskrivning

    Actual date/time

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    Timepoint
    Beskrivning

    Timepoint

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348792
    Pharmacokinetics Blood - Dosing date and time (Day 1 - 13)
    Beskrivning

    Pharmacokinetics Blood - Dosing date and time (Day 1 - 13)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    AM Dosing date and time
    Beskrivning

    AM Dosing date and time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C1264639
    UMLS CUI [1,3]
    C4331833
    PM Dosing date and time
    Beskrivning

    PM Dosing date and time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C1264639
    UMLS CUI [1,3]
    C1509133
    Pharmacokinetics Blood (Day 1 - 13)
    Beskrivning

    Pharmacokinetics Blood (Day 1 - 13)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Timepoint
    Beskrivning

    Timepoint

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348792
    Actual date/time
    Beskrivning

    Actual date/time

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    Pharmacokinetics Blood - Dosing date and time (Day 14 - 16)
    Beskrivning

    Pharmacokinetics Blood - Dosing date and time (Day 14 - 16)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    AM Dosing date and time
    Beskrivning

    AM Dosing date and time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C1264639
    PM Dosing date and time
    Beskrivning

    PM Dosing date and time

    Datatyp

    datetime

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C1264639
    UMLS CUI [1,3]
    C1509133
    Pharmacokinetics Blood (Day 14 - 16)
    Beskrivning

    Pharmacokinetics Blood (Day 14 - 16)

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0005767
    Timepoint
    Beskrivning

    Timepoint

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348792
    Actual date/time
    Beskrivning

    Actual date/time

    Datatyp

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    Tillbaka till toppen

    Similar models

    Pharmacokinetics Blood (Period 1 - 5; Day 1 - Day 16)

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Pharmacokinetics Blood - Dosing date and time (Period 1 - 5)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    C0178602 (UMLS CUI-3)
    C1264639 (UMLS CUI-4)
    Dosing date and time
    Item
    Dosing date and time
    datetime
    C0178602 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Item Group
    Repeat Pharmacokinetics Blood (Period 1 - 5)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    C0205341 (UMLS CUI-3)
    Actual date/time
    Item
    Actual date/time
    datetime
    C1264639 (UMLS CUI [1])
    Item
    Timepoint
    integer
    C2348792 (UMLS CUI [1])
    Timepoint
    Code List
    Timepoint
    CL Item
    Pre dose (1)
    CL Item
    15 mins (2)
    CL Item
    30 mins (3)
    CL Item
    1 hr (4)
    CL Item
    2 hr (5)
    CL Item
    4 hr (6)
    CL Item
    8 hr (7)
    CL Item
    12 hr (8)
    CL Item
    24 hr (9)
    Item Group
    Pharmacokinetics Blood - Dosing date and time (Day 1 - 13)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    AM Dosing date and time
    Item
    AM Dosing date and time
    datetime
    C0178602 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    C4331833 (UMLS CUI [1,3])
    PM Dosing date and time
    Item
    PM Dosing date and time
    datetime
    C0178602 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    C1509133 (UMLS CUI [1,3])
    Item Group
    Pharmacokinetics Blood (Day 1 - 13)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Timepoint
    integer
    C2348792 (UMLS CUI [1])
    Timepoint
    Code List
    Timepoint
    CL Item
    Pre dose (1)
    CL Item
    15 mins (2)
    CL Item
    30 mins (3)
    CL Item
    1 hr (4)
    CL Item
    2 hr (5)
    CL Item
    4 hr (6)
    CL Item
    8 hr (7)
    CL Item
    12 hr (8)
    CL Item
    12 hr:15 mins (9)
    CL Item
    12 hr: 30 mins (10)
    CL Item
    13 hr (11)
    CL Item
    14 hr (12)
    CL Item
    16 hr (13)
    CL Item
    20 hr (14)
    CL Item
    24 hr (15)
    CL Item
    36 hr (16)
    Actual date/time
    Item
    Actual date/time
    datetime
    C1264639 (UMLS CUI [1])
    Item Group
    Pharmacokinetics Blood - Dosing date and time (Day 14 - 16)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    AM Dosing date and time
    Item
    AM Dosing date and time
    datetime
    C0178602 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    PM Dosing date and time
    Item
    PM Dosing date and time
    datetime
    C0178602 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    C1509133 (UMLS CUI [1,3])
    Item Group
    Pharmacokinetics Blood (Day 14 - 16)
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Timepoint
    integer
    C2348792 (UMLS CUI [1])
    Timepoint
    Code List
    Timepoint
    CL Item
    Pre dose (1)
    CL Item
    15 mins (2)
    CL Item
    30 mins (3)
    CL Item
    1 hr (4)
    CL Item
    2 hr (5)
    CL Item
    4 hr (6)
    CL Item
    8 hr (7)
    CL Item
    12 hr (8)
    CL Item
    12 hr:15 mins (9)
    CL Item
    12 hr:30 mins (10)
    CL Item
    13 hr (11)
    CL Item
    14 hr (12)
    CL Item
    16 hr (13)
    CL Item
    20 hr (14)
    CL Item
    24 hr (15)
    CL Item
    36 hr (16)
    CL Item
    48 hr (17)
    CL Item
    60 hr (18)
    Actual date/time
    Item
    Actual date/time
    datetime
    C1264639 (UMLS CUI [1])
    Tillbaka till toppen 

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