0 Ratings
ID

33786

Description

Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Keywords

Versions (3)
  1. 10/25/18 10/25/18 -
  2. 12/27/18 12/27/18 -
  3. 3/4/19 3/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

December 27, 2018

DOI

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License

Creative Commons BY-NC 3.0
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    Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

    English

    Unscheduled Visit: Clinical Chemistry

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Description

    Subject Identifier

    Data type

    integer

    Local Laboratory Result Data - Clinical Chemistry
    Description

    Local Laboratory Result Data - Clinical Chemistry

    Alias
    UMLS CUI-1
    C0022885
    UMLS CUI-2
    C0008000
    Date and time sample taken
    Description

    Chemistry, Clinical; Sampling, Date in time, Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0870078
    UMLS CUI [1,3]
    C0011008
    UMLS CUI [1,4]
    C0040223
    Has the subject fasted?
    Description

    Chemistry, Clinical, Fasting

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0015663
    Glucose
    Description

    Chemistry, Clinical, Glucose measurement

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0337438
    mg/dL
    BUN
    Description

    Chemistry, Clinical, Blood urea nitrogen measurement

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0005845
    Creatinine
    Description

    Chemistry, Clinical, Creatinine measurement

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0201975
    Sodium
    Description

    Chemistry, Clinical; Sodium measurement

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0337443
    Potassium
    Description

    Chemistry, Clinical; Potassium measurement

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0202194
    Chloride
    Description

    Chemistry, Clinical; Chloride measurement

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0201952
    Carbon Dioxide
    Description

    Chemistry, Clinical; Carbon Dioxide

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0007012
    Calcium
    Description

    Chemistry, Clinical; Calcium measurement

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0201925
    Inorganic Phosphate
    Description

    Chemistry, Clinical; Inorganic Phosphates

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0031603
    Total Protein
    Description

    Chemistry, Clinical; Total Protein measurement

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0555903
    Albumin
    Description

    Chemistry, Clinical; Albumin measurement

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0201838
    Total Bilirubin
    Description

    Chemistry, Clinical; Bilirubin, total measurement

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0201913
    Direct Bilirubin
    Description

    Chemistry, Clinical; Bilirubin, direct measurement

    Data type

    float

    Alias
    UMLS CUI [1]
    C0201916
    Alkaline Phosphatase
    Description

    Chemistry, Clinical; Alkaline Phosphatase measurement

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0201850
    ALT
    Description

    Chemistry, Clinical; Alanine aminotransferase measurement

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0201836
    AST
    Description

    Chemistry, Clinical; Aspartate aminotransferase measurement

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0201899
    GGT
    Description

    Chemistry, Clinical; Gamma glutamyl transferase measurement

    Data type

    float

    Alias
    UMLS CUI [1]
    C0202035
    Uric acid
    Description

    Chemistry, Clinical; Uric acid

    Data type

    float

    Alias
    UMLS CUI [1,1]
    C0008000
    UMLS CUI [1,2]
    C0041980
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    Similar models

    Unscheduled Visit: Clinical Chemistry

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    Item Group
    Local Laboratory Result Data - Clinical Chemistry
    C0022885 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Chemistry, Clinical; Sampling, Date in time, Time
    Item
    Date and time sample taken
    datetime
    C0008000 (UMLS CUI [1,1])
    C0870078 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    C0040223 (UMLS CUI [1,4])
    Chemistry, Clinical, Fasting
    Item
    Has the subject fasted?
    boolean
    C0008000 (UMLS CUI [1,1])
    C0015663 (UMLS CUI [1,2])
    Chemistry, Clinical, Glucose measurement
    Item
    Glucose
    float
    C0008000 (UMLS CUI [1,1])
    C0337438 (UMLS CUI [1,2])
    Chemistry, Clinical, Blood urea nitrogen measurement
    Item
    BUN
    float
    C0008000 (UMLS CUI [1,1])
    C0005845 (UMLS CUI [1,2])
    Chemistry, Clinical, Creatinine measurement
    Item
    Creatinine
    float
    C0008000 (UMLS CUI [1,1])
    C0201975 (UMLS CUI [1,2])
    Chemistry, Clinical; Sodium measurement
    Item
    Sodium
    float
    C0008000 (UMLS CUI [1,1])
    C0337443 (UMLS CUI [1,2])
    Chemistry, Clinical; Potassium measurement
    Item
    Potassium
    float
    C0008000 (UMLS CUI [1,1])
    C0202194 (UMLS CUI [1,2])
    Chemistry, Clinical; Chloride measurement
    Item
    Chloride
    float
    C0008000 (UMLS CUI [1,1])
    C0201952 (UMLS CUI [1,2])
    Chemistry, Clinical; Carbon Dioxide
    Item
    Carbon Dioxide
    float
    C0008000 (UMLS CUI [1,1])
    C0007012 (UMLS CUI [1,2])
    Chemistry, Clinical; Calcium measurement
    Item
    Calcium
    float
    C0008000 (UMLS CUI [1,1])
    C0201925 (UMLS CUI [1,2])
    Chemistry, Clinical; Inorganic Phosphates
    Item
    Inorganic Phosphate
    float
    C0008000 (UMLS CUI [1,1])
    C0031603 (UMLS CUI [1,2])
    Chemistry, Clinical; Total Protein measurement
    Item
    Total Protein
    float
    C0008000 (UMLS CUI [1,1])
    C0555903 (UMLS CUI [1,2])
    Chemistry, Clinical; Albumin measurement
    Item
    Albumin
    float
    C0008000 (UMLS CUI [1,1])
    C0201838 (UMLS CUI [1,2])
    Chemistry, Clinical; Bilirubin, total measurement
    Item
    Total Bilirubin
    float
    C0008000 (UMLS CUI [1,1])
    C0201913 (UMLS CUI [1,2])
    Chemistry, Clinical; Bilirubin, direct measurement
    Item
    Direct Bilirubin
    float
    C0201916 (UMLS CUI [1])
    Chemistry, Clinical; Alkaline Phosphatase measurement
    Item
    Alkaline Phosphatase
    float
    C0008000 (UMLS CUI [1,1])
    C0201850 (UMLS CUI [1,2])
    Chemistry, Clinical; Alanine aminotransferase measurement
    Item
    ALT
    float
    C0008000 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    Chemistry, Clinical; Aspartate aminotransferase measurement
    Item
    AST
    float
    C0008000 (UMLS CUI [1,1])
    C0201899 (UMLS CUI [1,2])
    Chemistry, Clinical; Gamma glutamyl transferase measurement
    Item
    GGT
    float
    C0202035 (UMLS CUI [1])
    Chemistry, Clinical; Uric acid
    Item
    Uric acid
    float
    C0008000 (UMLS CUI [1,1])
    C0041980 (UMLS CUI [1,2])
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