ID

32030

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. 10/15/18 10/15/18 -
  2. 2/25/19 2/25/19 -
  3. 3/4/19 3/4/19 -
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

Physical Examination - Day 1 - Treatment Period 1

1 forms  
Physical Examination - Day1
Description

Physical Examination - Day1

Subject Identifier
Description

Subject Identifier

Data type

integer

Physical Examination
Description

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely: [different findings should be separated by either a (;) or (/)].

Data type

text

Date of Assessment
Description

Date of Assessment

Data type

date

Hair and Skin
Description

Hair and Skin

Data type

text

Lymph nodes
Description

Lymph nodes

Data type

text

Eyes
Description

Eyes

Data type

text

Ears, Nose, and Throat
Description

Ears, Nose, and Throat

Data type

text

Breasts
Description

Breasts

Data type

text

Respiratory
Description

Respiratory

Data type

text

Cardiovascular
Description

Cardiovascular

Data type

text

Abdomen
Description

Abdomen

Data type

text

Urogenital
Description

Urogenital

Data type

text

Pelvic
Description

Pelvic

Data type

text

Rectal
Description

Rectal

Data type

text

Musculoskeletal
Description

Musculoskeletal

Data type

text

Neurological
Description

Neurological

Data type

text

Mental Status
Description

Mental Status

Data type

text

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):

Data type

text

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

Vital Signs
Description

Vital Signs

Date
Description

Date

Data type

date

Time
Description

Time

Data type

time

Weight
Description

Weight

Data type

float

Measurement units
  • kg
kg
Body mass index
Description

Body mass index

Data type

float

Measurement units
  • kg / m2
kg / m2
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Similar models

Physical Examination - Day 1 - Treatment Period 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Physical Examination - Day1
Subject Identifier
Item
Subject Identifier
integer
Physical Examination
Item
Physical Examination
text
Date of Assessment
Item
Date of Assessment
date
Item
Hair and Skin
text
Hair and Skin
Code List
Hair and Skin
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Lymph nodes
text
Lymph nodes
Code List
Lymph nodes
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Eyes
text
Eyes
Code List
Eyes
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Ears, Nose, and Throat
text
Ears, Nose, and Throat
Code List
Ears, Nose, and Throat
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Breasts
text
Breasts
Code List
Breasts
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Item
Respiratory
text
Respiratory
Code List
Respiratory
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Cardiovascular
text
Cardiovascular
Code List
Cardiovascular
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Abdomen
text
Abdomen
Code List
Abdomen
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Urogenital
text
Urogenital
Code List
Urogenital
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Item
Pelvic
text
Pelvic
Code List
Pelvic
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Item
Rectal
text
Rectal
Code List
Rectal
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not Done (Not Done)
Item
Musculoskeletal
text
Musculoskeletal
Code List
Musculoskeletal
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Neurological
text
Neurological
Code List
Neurological
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Mental Status
text
Mental Status
Code List
Mental Status
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
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
Mark appropriate box(es):
Item
Mark appropriate box(es):
text
Item
Cocaine
text
Cocaine
Code List
Cocaine
CL Item
Positive (P)
CL Item
Negative (N)
Item
Amphetamines
text
Amphetamines
Code List
Amphetamines
CL Item
Positive (P)
CL Item
Negative (N)
Item
Benzodiazepines
text
Benzodiazepines
Code List
Benzodiazepines
CL Item
Positive (P)
CL Item
Negative (N)
Item
Cannabinoids
text
Cannabinoids
Code List
Cannabinoids
CL Item
Positive (P)
CL Item
Negative (N)
Item
Opiates
text
Opiates
Code List
Opiates
CL Item
Positive (P)
CL Item
Negative (N)
Item
Barbiturates
text
Barbiturates
Code List
Barbiturates
CL Item
Positive (P)
CL Item
Negative (N)
Item
Alcohol
text
Alcohol
Code List
Alcohol
CL Item
Positive (P)
CL Item
Negative (N)
Item
Cotinine
text
Cotinine
Code List
Cotinine
CL Item
Positive (P)
CL Item
Negative (N)
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
Vital Signs
Date
Item
Date
date
Time
Item
Time
time
Weight
Item
Weight
float
Body mass index
Item
Body mass index
float
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