ID

32165

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. 2/25/19 2/25/19 -
  3. 3/4/19 3/4/19 -
Copyright Holder

GSK group of companies

Uploaded on

October 22, 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

Part 2 - Screening Visit - Urine Screen + Serology

1 forms  
Administrative data
Description

Administrative data

Subject Identifier
Description

Subject Identifier

Data type

integer

Urine Drug, Alcohol and Cotinine Screen
Description

Urine Drug, Alcohol and Cotinine Screen

Date of sample taken
Description

Date of sample taken

Data type

date

Time of sample taken
Description

Time of sample taken

Data type

time

Mark appropriate box(es)
Description

Mark appropriate box(es)

Cocaine
Description

Cocaine

Data type

text

Amphetamines
Description

Amphetamines

Data type

text

Benzodiazepines
Description

Benzodiazepines

Data type

text

Cannabinoids
Description

Cannabinoids

Data type

text

Opiates
Description

Opiates

Data type

text

Barbiturates
Description

Barbiturates

Data type

text

Alcohol
Description

Alcohol

Data type

text

Cotinine
Description

Cotinine

Data type

text

If any of the above are positive, exclude subject from the study.
Description

If any of the above are positive, exclude subject from the study.

Data type

text

Serology - HIV, Hepatitis B & C Screen
Description

Serology - HIV, Hepatitis B & C Screen

Date sample taken
Description

Date sample taken

Data type

date

HIV antibody
Description

HIV antibody

Data type

text

Hepatitis B surface antigen
Description

Hepatitis B surface antigen

Data type

text

Hepatitis C antibody
Description

Hepatitis C antibody

Data type

text

If any of the above are positive, exclude subject from the study.
Description

If any of the above are positive, exclude subject from the study.

Data type

text

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Similar models

Part 2 - Screening Visit - Urine Screen + Serology

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Identifier
Item
Subject Identifier
integer
Item Group
Urine Drug, Alcohol and Cotinine Screen
Date of sample taken
Item
Date of sample taken
date
Time of sample taken
Item
Time of sample taken
time
Item Group
Mark appropriate box(es)
Item
Cocaine
text
Cocaine
Code List
Cocaine
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
text
Amphetamines
Code List
Amphetamines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
text
Benzodiazepines
Code List
Benzodiazepines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cannabinoids
text
Cannabinoids
Code List
Cannabinoids
CL Item
Positive (1)
CL Item
Negative (2)
Item
Opiates
text
Opiates
Code List
Opiates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Barbiturates
text
Barbiturates
Code List
Barbiturates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Alcohol
text
Alcohol
Code List
Alcohol
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cotinine
text
Cotinine
Code List
Cotinine
CL Item
Positive (1)
CL Item
Negative (2)
If any of the above are positive, exclude subject from the study.
Item
If any of the above are positive, exclude subject from the study.
text
Item Group
Serology - HIV, Hepatitis B & C Screen
Date sample taken
Item
Date sample taken
date
Item
HIV antibody
text
HIV antibody
Code List
HIV antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis B surface antigen
text
Hepatitis B surface antigen
Code List
Hepatitis B surface antigen
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis C antibody
text
Hepatitis C antibody
Code List
Hepatitis C antibody
CL Item
Positive (1)
CL Item
Negative (2)
If any of the above are positive, exclude subject from the study.
Item
If any of the above are positive, exclude subject from the study.
text
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