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ID

32390

Description

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

Mots-clés

Versions (2)
  1. 26/10/2018 26/10/2018 -
  2. 29/10/2018 29/10/2018 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

29 octobre 2018

DOI

Pour une demande vous connecter.

Licence

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

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    Pre-Dose Form

    1 Formulaires  
    1. StudyEvent: ODM
      1. Pre-Dose Form
    Administrative Data
    Description

    Administrative Data

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

    Visit Date

    Type de données

    date

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

    Subject Identifier

    Type de données

    text

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

    Study Period

    Type de données

    integer

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

    Vital Signs

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

    Sitting

    Type de données

    integer

    Unités de mesure
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Blood pressure (Diastolic)
    Description

    Sitting

    Type de données

    integer

    Unités de mesure
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    Heart rate
    Description

    Sitting

    Type de données

    integer

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

    Pharmacokinetics - Blood

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

    Time Relative to Dosing

    Type de données

    integer

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

    Date Sample Taken

    Type de données

    date

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

    Actual Time

    Type de données

    time

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

    3mL Sample Taken

    Type de données

    boolean

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

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

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C1299222 (Sample identification number)
    SNOMED
    372274003
    Retour au début de la page

    Similar models

    Pre-Dose Form

    1 Formulaires
    1. StudyEvent: ODM
      1. Pre-Dose Form
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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)
    Retour au début de la page 

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