0 Evaluaciones
ID

32390

Descripción

This ODM file contains a form for the documention required at the pre-dose visits. Study ID: 103880 Clinical Study ID: ARI103880 Study Title: An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Duagen,Zytefor,Avolve,Avodart,Avidart,Zyfetor; Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Prostatic Hyperplasia

Palabras clave

Versiones (2)
  1. 26/10/18 26/10/18 -
  2. 29/10/18 29/10/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

29 de octubre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880

    Inglés

    Pre-Dose Form

    1 formularios  
    1. StudyEvent: ODM
      1. Pre-Dose Form
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Visit Date
    Descripción

    Visit Date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Subject Identifier
    Descripción

    Subject Identifier

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Study Period
    Descripción

    Study Period

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2347804 (Clinical Trial Period)
    Vital Signs
    Descripción

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Blood pressure (Systolic)
    Descripción

    Sitting

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Blood pressure (Diastolic)
    Descripción

    Sitting

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    Heart rate
    Descripción

    Sitting

    Tipo de datos

    integer

    Unidades de medida
    • beats/minute
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/minute
    Pharmacokinetics - Blood
    Descripción

    Pharmacokinetics - Blood

    Alias
    UMLS CUI-1
    C0031327 (Drug Kinetics)
    UMLS CUI-2
    C0005767 (Blood)
    SNOMED
    87612001
    LOINC
    LP71680-0
    Planned Relative Time
    Descripción

    Time Relative to Dosing

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    Date Sample Taken
    Descripción

    Date Sample Taken

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Actual Time
    Descripción

    Actual Time

    Tipo de datos

    time

    Unidades de medida
    • Hr : Min
    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Hr : Min
    3mL Sample Taken
    Descripción

    3mL Sample Taken

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1277698 (Blood sample taken)
    SNOMED
    313334002
    Sample Number
    Descripción

    The sample number 100 is to be used in period 1, 200 in period 2 and 300 in period 3

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1299222 (Sample identification number)
    SNOMED
    372274003
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    Similar models

    Pre-Dose Form

    1 formularios
    1. StudyEvent: ODM
      1. Pre-Dose Form
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item
    Study Period
    integer
    C2347804 (UMLS CUI [1])
    Visit Type
    Code List
    Study Period
    CL Item
    Period 1 (1)
    CL Item
    Period 2 (2)
    CL Item
    Period 3 (3)
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Systolic blood 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
    Pharmacokinetics - Blood
    C0031327 (UMLS CUI-1)
    C0005767 (UMLS CUI-2)
    Item
    Planned Relative Time
    integer
    C0439564 (UMLS CUI [1])
    Planned Relative Time of Dosage
    Code List
    Planned Relative Time
    CL Item
    1. Pre-Dose (1)
    Date Sample Taken
    Item
    Date Sample Taken
    date
    C1302413 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    3mL Sample Taken
    Item
    3mL Sample Taken
    boolean
    C1277698 (UMLS CUI [1])
    Item
    Sample Number
    integer
    C1299222 (UMLS CUI [1])
    Sample Number
    Code List
    Sample Number
    CL Item
    100  (100)
    CL Item
    200 (200)
    CL Item
    300 (300)
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