ID

32035

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 (2)
  1. 10/15/18 10/15/18 -
  2. 2/25/19 2/25/19 -
Copyright Holder

GSK group of companies

Uploaded on

October 15, 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

Laboratory Result Data - Day 1 - Treatment Period 1

1 forms  
Haematology
Description

Haematology

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

Haematology Test
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

integer

Result
Description

1 = Hematocrit 2 = Haemoglobin 3 = Red Blood Cell Count 4 = MCV 5 = MCH 6 = MCHC 7 = Platelet Count 8 = White Blood Cell Count 9 = Neutrophils (Absolute) 10 = Neutrophils (%) 11 = Lymphocytes (Absolute) 12 = Lymphocytes (%) 13 = Monocytes (Absolute) 14 = Monocytes (%) 15 = Eosinophils (Absolute) 16 = Eosinophils (%) 17 = Basophils (Absolute) 18 = Basophils (%)

Data type

text

Clinical Chemistry
Description

Clinical Chemistry

Date of sample taken
Description

Date of sample taken

Data type

date

Time of sample taken
Description

Time of sample taken

Data type

time

Has the subject fasted?
Description

Has the subject fasted?

Data type

boolean

Clinical Chemistry Test
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

integer

Result
Description

1 = Glucose 2 = BUN 3 = Creatinine 4 = Sodium 5 = Potassium 6 = Chloride 7 = Carbon Dioxide 8 = Calcium 9 = Inorganic Phosphate 10 = Total Protein 11 = Albumin 12 = Total Bilirubin 13 = Direct Bilirubin 14 = Alkaline Phosphatase 15 = ALT 16 = AST 17 = GGT 18 = Uric acid

Data type

text

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Similar models

Laboratory Result Data - Day 1 - Treatment Period 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Haematology
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
Haematology Test
integer
Haematology Test
Code List
Haematology Test
CL Item
Hematocrit (1)
CL Item
Haemoglobin (2)
CL Item
Red Blood Cell Count (3)
CL Item
MCV (4)
CL Item
MCH (5)
CL Item
MCHC (6)
CL Item
Platelet Count (7)
CL Item
White Blood Cell Count (8)
CL Item
Neutrophils (Absolute) (9)
CL Item
Neutrophils (%) (10)
CL Item
Lymphocytes (Absolute) (11)
CL Item
Lymphocytes (%) (12)
CL Item
Monocytes (Absolute) (13)
CL Item
Monocytes (%) (14)
CL Item
Eosinophils (Absolute) (15)
CL Item
Eosinophils (%) (16)
CL Item
Basophils (Absolute) (17)
CL Item
Basophils (%) (18)
Result
Item
Result
text
Item Group
Clinical Chemistry
Date of sample taken
Item
Date of sample taken
date
Time of sample taken
Item
Time of sample taken
time
Has the subject fasted?
Item
Has the subject fasted?
boolean
Item
Clinical Chemistry Test
integer
Clinical Chemistry Test
Code List
Clinical Chemistry Test
CL Item
Glucose (1)
CL Item
BUN (2)
CL Item
Creatinine (3)
CL Item
Sodium (4)
CL Item
Potassium (5)
CL Item
Chloride (6)
CL Item
Carbon Dioxide (7)
CL Item
Calcium (8)
CL Item
Inorganic Phosphate (9)
CL Item
Total Protein (10)
CL Item
Albumin (11)
CL Item
Total Bilirubin  (12)
CL Item
Direct Bilirubin (13)
CL Item
Alkaline Phosphatase (14)
CL Item
ALT (15)
CL Item
AST (16)
CL Item
GGT (17)
CL Item
Uric acid (18)
Result
Item
Result
text
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