ID

34488

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. 10/24/18 10/24/18 -
  2. 1/17/19 1/17/19 -
  3. 3/4/19 3/4/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 17, 2019

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: Repeat Dose Phase - Day 23 - Pharmacokinetics (Blood, Dutasteride)

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Pharmacokinetics - Blood (Dutasteride)
Description

Pharmacokinetics - Blood (Dutasteride)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0754659
Planned Relative Time
Description

Pharmacokinetic aspects, Blood, Dutasteride, Relative Time, Planned

Data type

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0754659C0439564
UMLS CUI [1,4]
C1301732
Date Sample Taken
Description

Pharmacokinetic aspects, Blood, Dutasteride. Sampling, Date in time

Data type

date

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0754659
UMLS CUI [1,4]
C0870078
UMLS CUI [1,5]
C0011008
Actual Time
Description

Pharmacokinetic aspects, Blood, Dutasteride, Time

Data type

time

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0754659
UMLS CUI [1,4]
C0040223
Mark if Sample taken
Description

Pharmacokinetic aspects, Blood, Dutasteride, Sampling

Data type

boolean

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0754659
UMLS CUI [1,4]
C0870078
Sample Number
Description

Pharmacokinetic aspects, Blood, Dutasteride, Sample identification number

Data type

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0005767
UMLS CUI [1,3]
C0754659
UMLS CUI [1,4]
C1299222
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Similar models

Part 2: Repeat Dose Phase - Day 23 - Pharmacokinetics (Blood, Dutasteride)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Pharmacokinetics - Blood (Dutasteride)
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0754659 (UMLS CUI-3)
Item
Planned Relative Time
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0754659C0439564 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
Pharmacokinetic aspects, Blood, Dutasteride. Sampling, Date in time
Item
Date Sample Taken
date
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0754659 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
Pharmacokinetic aspects, Blood, Dutasteride, Time
Item
Actual Time
time
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0754659 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Dutasteride, Sampling
Item
Mark if Sample taken
boolean
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0754659 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
Item
Sample Number
integer
C0031328 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0754659 (UMLS CUI [1,3])
C1299222 (UMLS CUI [1,4])
Pharmacokinetic aspects, Blood, Sample identification number
Code List
Sample Number
CL Item
521 (1)
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