ID

34080

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. 10/22/18 10/22/18 -
  2. 1/14/19 1/14/19 -
  3. 3/4/19 3/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 14, 2019

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

Part 2 - Screening 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
CPK
Description

Chemistry, Clinical; Creatin kinase measurement

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0201973
TSH
Description

Chemistry, Clinical; Thyroid stimulating hormone measurement

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0202230
T4
Description

Chemistry, Clinical; T4 free measurement

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0202225
Triglycerides
Description

Chemistry, Clinical; Triglycerides measurement

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0202236
HDL
Description

Chemistry, Clinical; Serum HDL cholesterol measurement

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0428472
Calculated LDL
Description

Chemistry, Clinical; Serum LDL cholesterol measurement, Calculated

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0428474
UMLS CUI [1,3]
C0444686
Total Cholesterol
Description

Chemistry, Clinical; Serum total cholesterol measurement

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1445957
Total Testosterone
Description

Chemistry, Clinical; Total Testosterone Measurement

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0202227
Free Testosterone
Description

Chemistry, Clinical; Free Testosterone Measurement

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0202228
LH
Description

Chemistry, Clinical; Luteinizing hormone measurement

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0202123
FSH
Description

Chemistry, Clinical; Follicle stimulating hormone measurement

Data type

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0202022
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Similar models

Part 2 - Screening 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])
Chemistry, Clinical; Creatin kinase measurement
Item
CPK
float
C0008000 (UMLS CUI [1,1])
C0201973 (UMLS CUI [1,2])
Chemistry, Clinical; Thyroid stimulating hormone measurement
Item
TSH
float
C0008000 (UMLS CUI [1,1])
C0202230 (UMLS CUI [1,2])
Chemistry, Clinical; T4 free measurement
Item
T4
float
C0008000 (UMLS CUI [1,1])
C0202225 (UMLS CUI [1,2])
Chemistry, Clinical; Triglycerides measurement
Item
Triglycerides
float
C0008000 (UMLS CUI [1,1])
C0202236 (UMLS CUI [1,2])
Chemistry, Clinical; Serum HDL cholesterol measurement
Item
HDL
float
C0008000 (UMLS CUI [1,1])
C0428472 (UMLS CUI [1,2])
Chemistry, Clinical; Serum LDL cholesterol measurement, Calculated
Item
Calculated LDL
float
C0008000 (UMLS CUI [1,1])
C0428474 (UMLS CUI [1,2])
C0444686 (UMLS CUI [1,3])
Chemistry, Clinical; Serum total cholesterol measurement
Item
Total Cholesterol
float
C0008000 (UMLS CUI [1,1])
C1445957 (UMLS CUI [1,2])
Chemistry, Clinical; Total Testosterone Measurement
Item
Total Testosterone
float
C0008000 (UMLS CUI [1,1])
C0202227 (UMLS CUI [1,2])
Chemistry, Clinical; Free Testosterone Measurement
Item
Free Testosterone
float
C0008000 (UMLS CUI [1,1])
C0202228 (UMLS CUI [1,2])
Chemistry, Clinical; Luteinizing hormone measurement
Item
LH
float
C0008000 (UMLS CUI [1,1])
C0202123 (UMLS CUI [1,2])
Chemistry, Clinical; Follicle stimulating hormone measurement
Item
FSH
float
C0008000 (UMLS CUI [1,1])
C0202022 (UMLS CUI [1,2])
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