0 Evaluaciones
ID

41730

Descripción

Study ID: 111582 Clinical Study ID: 111582 Study Title: An Open Label Study to Examine the Effects of Low-fat and High-fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. Pharmacokinetics Blood measurements are supposed to be made ar the week 1, 2 and 3 visits.

Link

https://clinicaltrials.gov/ct2/show/NCT00821054

Palabras clave

Versiones (1)
  1. 9/1/21 9/1/21 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

9 de enero de 2021

DOI

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Licencia

Creative Commons BY-NC 4.0
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    Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054

    Inglés

    Pharmacokinetics, week 1, 2 and 3

    1 formularios  
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    visit date
    Descripción

    date of visit

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    subject ID
    Descripción

    subject ID

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    visit type
    Descripción

    visit type

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Dosing date and time
    Descripción

    Dosing date and time

    Alias
    UMLS CUI-1
    C0178602
    UMLS CUI-2
    C1264639
    Dosing date/time
    Descripción

    [read-only]

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C1264639
    predose
    Descripción

    please fill in the actual date/time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0439565
    UMLS CUI [1,3]
    C1264639
    0.25 hours post dose
    Descripción

    please fill in the actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C0040223
    0.5 hours post dose
    Descripción

    please fill in the actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C0040223
    1 hour post dose
    Descripción

    please fill in the actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C0040223
    1.5 hours post dose
    Descripción

    please fill in the actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C0040223
    2 hours post dose
    Descripción

    please fill in the actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C0040223
    2.5 hours post dose
    Descripción

    please fill in the actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C0040223
    3 hours post dose
    Descripción

    please fill in the actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C0040223
    4 hours post dose
    Descripción

    please fill in the actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C0040223
    6 hours post dose
    Descripción

    please fill in the actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C0040223
    8 hours post dose
    Descripción

    please fill in the actual date/time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1264639
    10 hours post dose
    Descripción

    please fill in the actual date/time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1264639
    3 hours post dose
    Descripción

    please fill in the actual date/time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0439568
    UMLS CUI [1,3]
    C1264639
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    Similar models

    Pharmacokinetics, week 1, 2 and 3

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    date of visit
    Item
    visit date
    date
    C1320303 (UMLS CUI [1])
    subject ID
    Item
    subject ID
    text
    C2348585 (UMLS CUI [1])
    Item
    visit type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    visit type
    Code List
    visit type
    CL Item
    week 1 (1)
    CL Item
    week 2  (2)
    CL Item
    week 3 (3)
    Item Group
    Dosing date and time
    C0178602 (UMLS CUI-1)
    C1264639 (UMLS CUI-2)
    Pharmacokinetics Dosing date/time
    Item
    Dosing date/time
    datetime
    C0031328 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C1264639 (UMLS CUI [1,3])
    Pharmacokinetics pre-dose date/time
    Item
    predose
    datetime
    C0031328 (UMLS CUI [1,1])
    C0439565 (UMLS CUI [1,2])
    C1264639 (UMLS CUI [1,3])
    Pharmacokinetics 0.25 hours post dose, time
    Item
    0.25 hours post dose
    time
    C0031328 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetics 0.5 hours post dose, time
    Item
    0.5 hours post dose
    time
    C0031328 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetics 1 hour post dose, time
    Item
    1 hour post dose
    time
    C0031328 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetics 1.5 hours post dose, time
    Item
    1.5 hours post dose
    time
    C0031328 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetics 2 hours post dose, time
    Item
    2 hours post dose
    time
    C0031328 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetics 2.5 hours post dose, time
    Item
    2.5 hours post dose
    time
    C0031328 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetics 3 hours post dose, time
    Item
    3 hours post dose
    time
    C0031328 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetics 4 hours post dose, time
    Item
    4 hours post dose
    time
    C0031328 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetics 6 hours post dose, time
    Item
    6 hours post dose
    time
    C0031328 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Pharmacokinetics 8 hours post dose date/time
    Item
    8 hours post dose
    datetime
    C0031328 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1264639 (UMLS CUI [1,3])
    Pharmacokinetics 10 hours post dose, date/time
    Item
    10 hours post dose
    datetime
    C0031328 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1264639 (UMLS CUI [1,3])
    Pharmacokinetics 24 hours post dose, date/time
    Item
    3 hours post dose
    datetime
    C0031328 (UMLS CUI [1,1])
    C0439568 (UMLS CUI [1,2])
    C1264639 (UMLS CUI [1,3])
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