ID

34080

Beschreibung

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

Stichworte

Versionen (3)
  1. 22.10.18 22.10.18 -
  2. 14.01.19 14.01.19 -
  3. 04.03.19 04.03.19 -
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GlaxoSmithKline

Hochgeladen am

14. Januar 2019

DOI

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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

Englisch

Part 2 - Screening Visit - Clinical Chemistry

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Local Laboratory Result Data - Clinical Chemistry
Beschreibung

Local Laboratory Result Data - Clinical Chemistry

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

Chemistry, Clinical; Sampling, Date in time, Time

Datentyp

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?
Beschreibung

Chemistry, Clinical, Fasting

Datentyp

boolean

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

Chemistry, Clinical, Glucose measurement

Datentyp

float

Maßeinheiten
  • mg/dL
Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0337438
mg/dL
BUN
Beschreibung

Chemistry, Clinical, Blood urea nitrogen measurement

Datentyp

float

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

Chemistry, Clinical, Creatinine measurement

Datentyp

float

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

Chemistry, Clinical; Sodium measurement

Datentyp

float

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

Chemistry, Clinical; Potassium measurement

Datentyp

float

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

Chemistry, Clinical; Chloride measurement

Datentyp

float

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

Chemistry, Clinical; Carbon Dioxide

Datentyp

float

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

Chemistry, Clinical; Calcium measurement

Datentyp

float

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

Chemistry, Clinical; Inorganic Phosphates

Datentyp

float

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

Chemistry, Clinical; Total Protein measurement

Datentyp

float

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

Chemistry, Clinical; Albumin measurement

Datentyp

float

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

Chemistry, Clinical; Bilirubin, total measurement

Datentyp

float

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

Chemistry, Clinical; Bilirubin, direct measurement

Datentyp

float

Alias
UMLS CUI [1]
C0201916
Alkaline Phosphatase
Beschreibung

Chemistry, Clinical; Alkaline Phosphatase measurement

Datentyp

float

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

Chemistry, Clinical; Alanine aminotransferase measurement

Datentyp

float

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

Chemistry, Clinical; Aspartate aminotransferase measurement

Datentyp

float

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

Chemistry, Clinical; Gamma glutamyl transferase measurement

Datentyp

float

Alias
UMLS CUI [1]
C0202035
Uric acid
Beschreibung

Chemistry, Clinical; Uric acid

Datentyp

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0041980
CPK
Beschreibung

Chemistry, Clinical; Creatin kinase measurement

Datentyp

float

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

Chemistry, Clinical; Thyroid stimulating hormone measurement

Datentyp

float

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

Chemistry, Clinical; T4 free measurement

Datentyp

float

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

Chemistry, Clinical; Triglycerides measurement

Datentyp

float

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

Chemistry, Clinical; Serum HDL cholesterol measurement

Datentyp

float

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

Chemistry, Clinical; Serum LDL cholesterol measurement, Calculated

Datentyp

float

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

Chemistry, Clinical; Serum total cholesterol measurement

Datentyp

float

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

Chemistry, Clinical; Total Testosterone Measurement

Datentyp

float

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

Chemistry, Clinical; Free Testosterone Measurement

Datentyp

float

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

Chemistry, Clinical; Luteinizing hormone measurement

Datentyp

float

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

Chemistry, Clinical; Follicle stimulating hormone measurement

Datentyp

float

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0202022
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Ähnliche Modelle

Part 2 - Screening Visit - Clinical Chemistry

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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