0 Ratings
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

Keywords

Versions (2)
  1. 10/26/18 10/26/18 -
  2. 10/29/18 10/29/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 29, 2018

DOI

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License

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

    English

    Pre-Dose Form

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

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Subject Identifier
    Description

    Subject Identifier

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Study Period
    Description

    Study Period

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2347804
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Blood pressure (Systolic)
    Description

    Sitting

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Blood pressure (Diastolic)
    Description

    Sitting

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Heart rate
    Description

    Sitting

    Data type

    integer

    Measurement units
    • beats/minute
    Alias
    UMLS CUI [1]
    C0018810
    beats/minute
    Pharmacokinetics - Blood
    Description

    Pharmacokinetics - Blood

    Alias
    UMLS CUI-1
    C0031327
    UMLS CUI-2
    C0005767
    Planned Relative Time
    Description

    Time Relative to Dosing

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0439564
    Date Sample Taken
    Description

    Date Sample Taken

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    Actual Time
    Description

    Actual Time

    Data type

    time

    Measurement units
    • Hr : Min
    Alias
    UMLS CUI [1]
    C0040223
    Hr : Min
    3mL Sample Taken
    Description

    3mL Sample Taken

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1277698
    Sample Number
    Description

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

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1299222
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    Similar models

    Pre-Dose Form

    1 forms
    1. StudyEvent: ODM
      1. Pre-Dose Form
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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