ID

32165

Beschrijving

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

Trefwoorden

  1. 22-10-18 22-10-18 -
  2. 25-02-19 25-02-19 -
  3. 04-03-19 04-03-19 -
Houder van rechten

GSK group of companies

Geüploaded op

22 oktober 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

Part 2 - Screening Visit - Urine Screen + Serology

Administrative data
Beschrijving

Administrative data

Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

Urine Drug, Alcohol and Cotinine Screen
Beschrijving

Urine Drug, Alcohol and Cotinine Screen

Date of sample taken
Beschrijving

Date of sample taken

Datatype

date

Time of sample taken
Beschrijving

Time of sample taken

Datatype

time

Mark appropriate box(es)
Beschrijving

Mark appropriate box(es)

Cocaine
Beschrijving

Cocaine

Datatype

text

Amphetamines
Beschrijving

Amphetamines

Datatype

text

Benzodiazepines
Beschrijving

Benzodiazepines

Datatype

text

Cannabinoids
Beschrijving

Cannabinoids

Datatype

text

Opiates
Beschrijving

Opiates

Datatype

text

Barbiturates
Beschrijving

Barbiturates

Datatype

text

Alcohol
Beschrijving

Alcohol

Datatype

text

Cotinine
Beschrijving

Cotinine

Datatype

text

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

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

Datatype

text

Serology - HIV, Hepatitis B & C Screen
Beschrijving

Serology - HIV, Hepatitis B & C Screen

Date sample taken
Beschrijving

Date sample taken

Datatype

date

HIV antibody
Beschrijving

HIV antibody

Datatype

text

Hepatitis B surface antigen
Beschrijving

Hepatitis B surface antigen

Datatype

text

Hepatitis C antibody
Beschrijving

Hepatitis C antibody

Datatype

text

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

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

Datatype

text

Similar models

Part 2 - Screening Visit - Urine Screen + Serology

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Code List
Cocaine
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
text
Code List
Amphetamines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
text
Code List
Benzodiazepines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cannabinoids
text
Code List
Cannabinoids
CL Item
Positive (1)
CL Item
Negative (2)
Item
Opiates
text
Code List
Opiates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Barbiturates
text
Code List
Barbiturates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Alcohol
text
Code List
Alcohol
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cotinine
text
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
Code List
HIV antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis B surface antigen
text
Code List
Hepatitis B surface antigen
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis C antibody
text
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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