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ID

32281

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

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

GSK group of companies

Uploaded on

October 25, 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

    Unscheduled Visit: Clinical Chemistry Results Form

    Administrative data
    Description

    Administrative data

    Subject Identifier
    Description

    Subject Identifier

    Data type

    integer

    Clinical Chemistry
    Description

    Clinical Chemistry

    Date sample taken
    Description

    Date sample taken

    Data type

    date

    Time sample taken
    Description

    Time sample taken

    Data type

    time

    Has the subject fasted?
    Description

    Has the subject fasted?

    Data type

    boolean

    Clinical Chemistry Tests and Results
    Description

    Clinical Chemistry Tests and Results

    Glucose
    Description

    Glucose

    Data type

    float

    Measurement units
    • mg/dL
    mg/dL
    BUN
    Description

    BUN

    Data type

    float

    Creatinine
    Description

    Creatinine

    Data type

    float

    Sodium
    Description

    Sodium

    Data type

    float

    Potassium
    Description

    Potassium

    Data type

    float

    Chloride
    Description

    Chloride

    Data type

    float

    Carbon Dioxide
    Description

    Carbon Dioxide

    Data type

    float

    Calcium
    Description

    Calcium

    Data type

    float

    Inorganic Phosphate
    Description

    Inorganic Phosphate

    Data type

    float

    Total Protein
    Description

    Total Protein

    Data type

    float

    Albumin
    Description

    Albumin

    Data type

    float

    Total Bilirubin
    Description

    Total Bilirubin

    Data type

    float

    Direct Bilirubin
    Description

    Direct Bilirubin

    Data type

    float

    Alkaline Phosphatase
    Description

    Alkaline Phosphatase

    Data type

    float

    ALT
    Description

    ALT

    Data type

    float

    AST
    Description

    AST

    Data type

    float

    GGT
    Description

    GGT

    Data type

    float

    Uric acid
    Description

    Uric acid

    Data type

    float

    If the laboratory results meet the protocol definition of an adverse event, record the details on the Non-Serious Adverse Events page or Serious Adverse Event page.
    Description

    If the laboratory results meet the protocol definition of an adverse event, record the details on the Non-Serious Adverse Events page or Serious Adverse Event page.

    Data type

    text

    Similar models

    Unscheduled Visit: Clinical Chemistry Results Form

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    Subject Identifier
    Item
    Subject Identifier
    integer
    Item Group
    Clinical Chemistry
    Date sample taken
    Item
    Date sample taken
    date
    Time sample taken
    Item
    Time sample taken
    time
    Has the subject fasted?
    Item
    Has the subject fasted?
    boolean
    Item Group
    Clinical Chemistry Tests and Results
    Glucose
    Item
    Glucose
    float
    BUN
    Item
    BUN
    float
    Creatinine
    Item
    Creatinine
    float
    Sodium
    Item
    Sodium
    float
    Potassium
    Item
    Potassium
    float
    Chloride
    Item
    Chloride
    float
    Carbon Dioxide
    Item
    Carbon Dioxide
    float
    Calcium
    Item
    Calcium
    float
    Inorganic Phosphate
    Item
    Inorganic Phosphate
    float
    Total Protein
    Item
    Total Protein
    float
    Albumin
    Item
    Albumin
    float
    Total Bilirubin
    Item
    Total Bilirubin
    float
    Direct Bilirubin
    Item
    Direct Bilirubin
    float
    Alkaline Phosphatase
    Item
    Alkaline Phosphatase
    float
    ALT
    Item
    ALT
    float
    AST
    Item
    AST
    float
    GGT
    Item
    GGT
    float
    Uric acid
    Item
    Uric acid
    float
    If the laboratory results meet the protocol definition of an adverse event, record the details on the Non-Serious Adverse Events page or Serious Adverse Event page.
    Item
    If the laboratory results meet the protocol definition of an adverse event, record the details on the Non-Serious Adverse Events page or Serious Adverse Event page.
    text

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