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ID

35380

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

Mots-clés

  1. 25/10/2018 25/10/2018 -
  2. 27/12/2018 27/12/2018 -
  3. 04/03/2019 04/03/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

4 mars 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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    Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

    Unscheduled Visit: Clinical Chemistry

    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Subject Identifier
    Description

    Clinical Trial Subject Unique Identifier

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Local Laboratory Result Data - Clinical Chemistry
    Description

    Local Laboratory Result Data - Clinical Chemistry

    Alias
    UMLS CUI-1
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI-2
    C0008000 (Chemistry, Clinical)
    Date and time sample taken
    Description

    Chemistry, Clinical; Sampling, Date in time, Time

    Type de données

    datetime

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0870078 (Sampling)
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,4]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Has the subject fasted?
    Description

    Chemistry, Clinical, Fasting

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0015663 (Fasting)
    SNOMED
    16985007
    LOINC
    LA11831-7
    Glucose
    Description

    Chemistry, Clinical, Glucose measurement

    Type de données

    float

    Unités de mesure
    • mg/dL
    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0337438 (Glucose measurement)
    SNOMED
    36048009
    mg/dL
    BUN
    Description

    Chemistry, Clinical, Blood urea nitrogen measurement

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0005845 (Blood urea nitrogen measurement)
    SNOMED
    105011006
    Creatinine
    Description

    Chemistry, Clinical, Creatinine measurement

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0201975 (Creatinine measurement)
    SNOMED
    70901006
    Sodium
    Description

    Chemistry, Clinical; Sodium measurement

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0337443 (Sodium measurement)
    SNOMED
    25197003
    Potassium
    Description

    Chemistry, Clinical; Potassium measurement

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0202194 (Potassium measurement)
    SNOMED
    59573005
    Chloride
    Description

    Chemistry, Clinical; Chloride measurement

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0201952 (Chloride measurement)
    SNOMED
    46511006
    Carbon Dioxide
    Description

    Chemistry, Clinical; Carbon Dioxide

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0007012 (carbon dioxide)
    SNOMED
    31811003
    Calcium
    Description

    Chemistry, Clinical; Calcium measurement

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0201925 (Calcium measurement)
    SNOMED
    71878006
    Inorganic Phosphate
    Description

    Chemistry, Clinical; Inorganic Phosphates

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0031603 (Phosphates)
    Total Protein
    Description

    Chemistry, Clinical; Total Protein measurement

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0555903 (Total protein measurement)
    SNOMED
    304383000
    Albumin
    Description

    Chemistry, Clinical; Albumin measurement

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0201838 (Albumin measurement)
    SNOMED
    26758005
    Total Bilirubin
    Description

    Chemistry, Clinical; Bilirubin, total measurement

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0201913 (Bilirubin, total measurement)
    SNOMED
    359986008
    Direct Bilirubin
    Description

    Chemistry, Clinical; Bilirubin, direct measurement

    Type de données

    float

    Alias
    UMLS CUI [1]
    C0201916 (Bilirubin, direct measurement)
    SNOMED
    39748002
    Alkaline Phosphatase
    Description

    Chemistry, Clinical; Alkaline Phosphatase measurement

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0201850 (Alkaline phosphatase measurement)
    SNOMED
    88810008
    ALT
    Description

    Chemistry, Clinical; Alanine aminotransferase measurement

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0201836 (Alanine aminotransferase measurement)
    SNOMED
    34608000
    AST
    Description

    Chemistry, Clinical; Aspartate aminotransferase measurement

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0201899 (Aspartate aminotransferase measurement)
    SNOMED
    45896001
    GGT
    Description

    Chemistry, Clinical; Gamma glutamyl transferase measurement

    Type de données

    float

    Alias
    UMLS CUI [1]
    C0202035 (Gamma glutamyl transferase measurement)
    SNOMED
    69480007
    Uric acid
    Description

    Chemistry, Clinical; Uric acid

    Type de données

    float

    Alias
    UMLS CUI [1,1]
    C0008000 (Chemistry, Clinical)
    UMLS CUI [1,2]
    C0041980 (uric acid)
    SNOMED
    1710001

    Similar models

    Unscheduled Visit: Clinical Chemistry

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    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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