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ID

36956

Beschrijving

Study ID: 102146 Clinical Study ID: SUM102146 Study Title: An open-label, randomized, three-period crossover study to demonstrate the bioequivalence of sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose after dose-normalization, and to assess the relative bioavailability of 4 mg sumatriptan injected using the STATdose device compared to 4 mg sumatriptan injected manually 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

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Versies (1)
  1. 23-06-19 23-06-19 -
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GlaxoSmithKline

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23 juni 2019

DOI

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Creative Commons BY-NC 3.0
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    Bioequivalence of Sumatriptan 4 mg STATdose to IMITREX™ 6 mg STATdose; 102146

    Engels

    Dosing Session 3

    1 Formulieren  
    1. StudyEvent: ODM
      1. Dosing Session 3
    Administrative Data
    Beschrijving

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject number
    Beschrijving

    Clinical Trial Subject Unique Identifier

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Pregnancy Test
    Beschrijving

    Pregnancy Test

    Alias
    UMLS CUI-1
    C0032976
    Is a pregnancy test applicable?
    Beschrijving

    Pregnancy Tests, Applicable

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1706839
    If YES, was pregnancy test performed?
    Beschrijving

    Pregnancy Tests, Diagnostic procedures performed

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C3259360
    Date pregnancy sample taken
    Beschrijving

    Pregnancy Tests, Sampling, Date in time

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    If YES, pregnancy test result, check one
    Beschrijving

    Pregnancy Tests, Result

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C1274040
    Drugs of Abuse
    Beschrijving

    Drugs of Abuse

    Alias
    UMLS CUI-1
    C0013146
    Date sample taken
    Beschrijving

    Drug screen, Sampling, Date in time

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0373483
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    Drug
    Beschrijving

    Drug screen, Illicit Drugs

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0373483
    UMLS CUI [1,2]
    C0086190
    Result
    Beschrijving

    Drug screen, Result

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0373483
    UMLS CUI [1,2]
    C1274040
    Vital Signs
    Beschrijving

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date
    Beschrijving

    Vital Signs Date

    Datatype

    date

    Alias
    UMLS CUI [1]
    C2826644
    Planned Time
    Beschrijving

    Vital Signs Time, Planned

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C2826762
    UMLS CUI [1,2]
    C1301732
    Blood pressure systolic
    Beschrijving

    Systolic Pressure

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0871470
    Blood pressure diastolic
    Beschrijving

    Diastolic blood pressure

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0428883
    Heart rate
    Beschrijving

    Heart rate

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0018810
    Pharmacokinetic Sampling
    Beschrijving

    Pharmacokinetic Sampling

    Alias
    UMLS CUI-1
    C0031328
    UMLS CUI-2
    C0870078
    Row number
    Beschrijving

    Pharmacokinetic aspects, Sampling, Numbers

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0851347
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0237753
    Date
    Beschrijving

    Pharmacokinetic aspects, Sampling, Date in time

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    Planned relative time
    Beschrijving

    Pharmacokinetic aspects, Sampling, Relative time, Planned

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0851347
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0439564
    UMLS CUI [1,4]
    C1301732
    Actual time
    Beschrijving

    Pharmacokinetic aspects, Sampling, Time

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0040223
    Sample number
    Beschrijving

    Pharmacokinetic aspects, Sampling, Numbers

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0237753
    5 mL sample, check if taken
    Beschrijving

    Pharmacokinetic aspects, Sampling, Taken

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C1883727
    Investigational Product
    Beschrijving

    Investigational Product

    Alias
    UMLS CUI-1
    C0304229
    Start Date
    Beschrijving

    Experimental drug, Start Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0808070
    Stop Date
    Beschrijving

    Experimental drug, End Date

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0806020
    Were there any significant changes to investigational product?
    Beschrijving

    Experimental drug, Changed status

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0443172
    If YES, specify investigational product changes, dates, and reasons
    Beschrijving

    Experimental drug, Changed status, Details

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0443172
    UMLS CUI [1,3]
    C1522508
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    Similar models

    Dosing Session 3

    1 Formulieren
    1. StudyEvent: ODM
      1. Dosing Session 3
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Pregnancy Test
    C0032976 (UMLS CUI-1)
    Pregnancy Tests, Applicable
    Item
    Is a pregnancy test applicable?
    boolean
    C0032976 (UMLS CUI [1,1])
    C1706839 (UMLS CUI [1,2])
    Pregnancy Tests, Diagnostic procedures performed
    Item
    If YES, was pregnancy test performed?
    boolean
    C0032976 (UMLS CUI [1,1])
    C3259360 (UMLS CUI [1,2])
    Pregnancy Tests, Sampling, Date in time
    Item
    Date pregnancy sample taken
    date
    C0032976 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    If YES, pregnancy test result, check one
    text
    C0032976 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Pregnancy Tests, Result
    Code List
    If YES, pregnancy test result, check one
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item Group
    Drugs of Abuse
    C0013146 (UMLS CUI-1)
    Drug screen, Sampling, Date in time
    Item
    Date sample taken
    date
    C0373483 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Drug
    text
    C0373483 (UMLS CUI [1,1])
    C0086190 (UMLS CUI [1,2])
    Drug screen, Illicit Drugs
    Code List
    Drug
    CL Item
    Opiates (1)
    CL Item
    Benzoylecgonine (cocaine metabolite) (2)
    CL Item
    Barbiturates (3)
    CL Item
    Amphetamines (4)
    CL Item
    Benzodiazepines  (5)
    CL Item
    Cannabinoids  (6)
    CL Item
    Alcohol (7)
    Item
    Result
    text
    C0373483 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Drug screen, Result
    Code List
    Result
    CL Item
    Positive (1)
    CL Item
    Negative (2)
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Vital Signs Date
    Item
    Date
    date
    C2826644 (UMLS CUI [1])
    Item
    Planned Time
    text
    C2826762 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    Vital Signs Time, Planned
    Code List
    Planned Time
    CL Item
    Pre-dose (1)
    CL Item
    15 min Post-dose (2)
    Systolic Pressure
    Item
    Blood pressure systolic
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Blood pressure diastolic
    integer
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    Pharmacokinetic Sampling
    C0031328 (UMLS CUI-1)
    C0870078 (UMLS CUI-2)
    Item
    Row number
    text
    C0851347 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Pharmacokinetic aspects, Sampling, Relative time, Planned
    Code List
    Row number
    CL Item
    1 (1)
    CL Item
    2 (2)
    CL Item
    3 (3)
    CL Item
    4 (4)
    CL Item
    5 (5)
    CL Item
    6 (6)
    CL Item
    7 (7)
    CL Item
    8 (8)
    CL Item
    9 (9)
    CL Item
    10 (10)
    CL Item
    11 (11)
    CL Item
    12 (12)
    CL Item
    13 (13)
    CL Item
    14 (14)
    CL Item
    15 (15)
    CL Item
    16 (16)
    CL Item
    17 (17)
    CL Item
    18 (18)
    CL Item
    19 (19)
    Pharmacokinetic aspects, Sampling, Date in time
    Item
    Date
    date
    C0031328 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Item
    Planned relative time
    text
    C0851347 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0439564 (UMLS CUI [1,3])
    C1301732 (UMLS CUI [1,4])
    Pharmacokinetic aspects, Sampling, Relative time, Planned
    Code List
    Planned relative time
    CL Item
    Pre-dose (1)
    CL Item
    Record time of dose of Investigational Product (2)
    CL Item
    2 min post-dose (3)
    CL Item
    5 min post-dose (4)
    CL Item
    10 min post-dose (5)
    CL Item
    15 min post-dose (6)
    CL Item
    20 min post-dose (7)
    CL Item
    30 min post-dose (8)
    CL Item
    45 min post-dose (9)
    CL Item
    60 min post-dose (10)
    CL Item
    1.25 hr post-dose (11)
    CL Item
    1.5 hr post-dose (12)
    CL Item
    2 hr post-dose (13)
    CL Item
    2.5 hr post-dose (14)
    CL Item
    3 hr post-dose (15)
    CL Item
    4 hr post-dose (16)
    CL Item
    6 hr post-dose (17)
    CL Item
    8 hr post-dose (18)
    CL Item
    12 hr post-dose (19)
    Pharmacokinetic aspects, Sampling, Time
    Item
    Actual time
    time
    C0031328 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    Sample number
    text
    C0031328 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0237753 (UMLS CUI [1,3])
    Pharmacokinetic aspects, Sampling, Numbers
    Code List
    Sample number
    CL Item
    BLD037 (1)
    CL Item
    - (2)
    CL Item
    BLD038 (3)
    CL Item
    BLD039 (4)
    CL Item
    BLD040 (5)
    CL Item
    BLD041 (6)
    CL Item
    BLD042 (7)
    CL Item
    BLD043 (8)
    CL Item
    BLD044 (9)
    CL Item
    BLD045 (10)
    CL Item
    BLD046 (11)
    CL Item
    BLD047 (12)
    CL Item
    BLD048 (13)
    CL Item
    BLD049 (14)
    CL Item
    BLD050 (15)
    CL Item
    BLD051 (16)
    CL Item
    BLD052 (17)
    CL Item
    BLD053 (18)
    CL Item
    BLD054 (19)
    Pharmacokinetic aspects, Sampling, Taken
    Item
    5 mL sample, check if taken
    boolean
    C0031328 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C1883727 (UMLS CUI [1,3])
    Item Group
    Investigational Product
    C0304229 (UMLS CUI-1)
    Experimental drug, Start Date
    Item
    Start Date
    date
    C0304229 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Experimental drug, End Date
    Item
    Stop Date
    date
    C0304229 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Experimental drug, Changed status
    Item
    Were there any significant changes to investigational product?
    boolean
    C0304229 (UMLS CUI [1,1])
    C0443172 (UMLS CUI [1,2])
    Experimental drug, Changed status, Details
    Item
    If YES, specify investigational product changes, dates, and reasons
    text
    C0304229 (UMLS CUI [1,1])
    C0443172 (UMLS CUI [1,2])
    C1522508 (UMLS CUI [1,3])
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