ID

32165

Beskrivning

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

Nyckelord

  1. 2018-10-22 2018-10-22 -
  2. 2019-02-25 2019-02-25 -
  3. 2019-03-04 2019-03-04 -
Rättsinnehavare

GSK group of companies

Uppladdad den

22 oktober 2018

DOI

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Licens

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
Beskrivning

Administrative data

Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Urine Drug, Alcohol and Cotinine Screen
Beskrivning

Urine Drug, Alcohol and Cotinine Screen

Date of sample taken
Beskrivning

Date of sample taken

Datatyp

date

Time of sample taken
Beskrivning

Time of sample taken

Datatyp

time

Mark appropriate box(es)
Beskrivning

Mark appropriate box(es)

Cocaine
Beskrivning

Cocaine

Datatyp

text

Amphetamines
Beskrivning

Amphetamines

Datatyp

text

Benzodiazepines
Beskrivning

Benzodiazepines

Datatyp

text

Cannabinoids
Beskrivning

Cannabinoids

Datatyp

text

Opiates
Beskrivning

Opiates

Datatyp

text

Barbiturates
Beskrivning

Barbiturates

Datatyp

text

Alcohol
Beskrivning

Alcohol

Datatyp

text

Cotinine
Beskrivning

Cotinine

Datatyp

text

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

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

Datatyp

text

Serology - HIV, Hepatitis B & C Screen
Beskrivning

Serology - HIV, Hepatitis B & C Screen

Date sample taken
Beskrivning

Date sample taken

Datatyp

date

HIV antibody
Beskrivning

HIV antibody

Datatyp

text

Hepatitis B surface antigen
Beskrivning

Hepatitis B surface antigen

Datatyp

text

Hepatitis C antibody
Beskrivning

Hepatitis C antibody

Datatyp

text

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

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

Datatyp

text

Similar models

Part 2 - Screening Visit - Urine Screen + Serology

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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