ID

32165

Descripción

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

Palabras clave

  1. 22/10/18 22/10/18 -
  2. 25/2/19 25/2/19 -
  3. 4/3/19 4/3/19 -
Titular de derechos de autor

GSK group of companies

Subido en

22 de octubre de 2018

DOI

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Licencia

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
Descripción

Administrative data

Subject Identifier
Descripción

Subject Identifier

Tipo de datos

integer

Urine Drug, Alcohol and Cotinine Screen
Descripción

Urine Drug, Alcohol and Cotinine Screen

Date of sample taken
Descripción

Date of sample taken

Tipo de datos

date

Time of sample taken
Descripción

Time of sample taken

Tipo de datos

time

Mark appropriate box(es)
Descripción

Mark appropriate box(es)

Cocaine
Descripción

Cocaine

Tipo de datos

text

Amphetamines
Descripción

Amphetamines

Tipo de datos

text

Benzodiazepines
Descripción

Benzodiazepines

Tipo de datos

text

Cannabinoids
Descripción

Cannabinoids

Tipo de datos

text

Opiates
Descripción

Opiates

Tipo de datos

text

Barbiturates
Descripción

Barbiturates

Tipo de datos

text

Alcohol
Descripción

Alcohol

Tipo de datos

text

Cotinine
Descripción

Cotinine

Tipo de datos

text

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

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

Tipo de datos

text

Serology - HIV, Hepatitis B & C Screen
Descripción

Serology - HIV, Hepatitis B & C Screen

Date sample taken
Descripción

Date sample taken

Tipo de datos

date

HIV antibody
Descripción

HIV antibody

Tipo de datos

text

Hepatitis B surface antigen
Descripción

Hepatitis B surface antigen

Tipo de datos

text

Hepatitis C antibody
Descripción

Hepatitis C antibody

Tipo de datos

text

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

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

Tipo de datos

text

Similar models

Part 2 - Screening Visit - Urine Screen + Serology

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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