0 Ratings
ID

32105

Description

This ODM file contains the form to record the pharmacokinetics. To be assessed at Day 1 of Period 1 and 2. Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Keywords

Versions (2)
  1. 10/12/18 10/12/18 -
  2. 10/17/18 10/17/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 17, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396

    English

    Pharmacokinetics

    1 forms  
    1. StudyEvent: ODM
      1. Pharmacokinetics
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Visit Type
    Description

    Visit Type

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0545082 (Visit)
    Pharmacokinetics - Blood
    Description

    Pharmacokinetics - Blood

    Alias
    UMLS CUI-1
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI-2
    C0005767 (Blood)
    SNOMED
    87612001
    LOINC
    LP71680-0
    Planned Relative Time Time Relative to Dosing
    Description

    Time Relative to Dosing 1 48 and 72 hour PK samples only apply following TREXIMA administration. Sample number indicated in brackets; starting with 1... are the sample numbers in period 1, starting with 2... those in period 2.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI [1,2]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    Scheduled Time
    Description

    Scheduled Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    UMLS CUI [1,2]
    C1301732 (Planned)
    SNOMED
    397943006
    LOINC
    LA20099-0
    Date sample taken
    Description

    Date sample taken

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Actual time
    Description

    Actual time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    5 mL Sample Check if Taken
    Description

    Sample taken

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
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    Similar models

    Pharmacokinetics

    1 forms
    1. StudyEvent: ODM
      1. Pharmacokinetics
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item
    Visit Type
    integer
    C0545082 (UMLS CUI [1])
    Visit Type
    Code List
    Visit Type
    CL Item
    Day 1 of Period 1 (1)
    CL Item
    Day 1 of Period 2 (2)
    Item Group
    Pharmacokinetics - Blood
    C0031328 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Planned Relative Time Time Relative to Dosing
    text
    C0031328 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Planned Relative Time
    Code List
    Planned Relative Time Time Relative to Dosing
    CL Item
    Pre-Dose (101, 201) (1)
    CL Item
    5 minutes (102, 202) (2)
    CL Item
    10 minutes (103, 203) (3)
    CL Item
    15 minutes (104, 204) (4)
    CL Item
    20 minutes (105, 205) (5)
    CL Item
    25 minutes (106, 206) (6)
    CL Item
    30 minutes (107, 207) (7)
    CL Item
    40 minutes (108, 208) (8)
    CL Item
    50 minutes (109, 209) (9)
    CL Item
    60 minutes (110, 210) (10)
    CL Item
    75 minutes (111, 211) (11)
    CL Item
    90 minutes (112, 212) (12)
    CL Item
    2 hours (113, 213) (13)
    CL Item
    2.5 hours (114, 214) (14)
    CL Item
    3 hours (115, 215) (15)
    CL Item
    4 hours (116, 216) (16)
    CL Item
    6 hours (117, 217) (17)
    CL Item
    8 hours (118, 218) (18)
    CL Item
    10 hours (119, 219) (19)
    CL Item
    12 hours (120, 220) (20)
    CL Item
    16 hours (121, 221) (21)
    CL Item
    24 hours (122, 222) (22)
    CL Item
    48 hours1 (123, 223) (23)
    CL Item
    72 hours1 (124, 224) (24)
    Scheduled Time
    Item
    Scheduled Time
    time
    C0040223 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    Date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Actual time
    Item
    Actual time
    time
    C0031328 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Sample taken
    Item
    5 mL Sample Check if Taken
    boolean
    C0200345 (UMLS CUI [1])
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