ID

32231

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 (1)
  1. 10/24/18 10/24/18 -
Copyright Holder

GSK group of companies

Uploaded on

October 24, 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

Part 2: Repeat Dose Phase - Day 21 - Treatment confirmation

1 forms  
Administrative data
Description

Administrative data

Subject Identifier
Description

Subject Identifier

Data type

integer

Investigational Product
Description

Investigational Product

Planned Timepoint
Description

Planned Timepoint

Data type

integer

Investigational Product
Description

Investigational Product

Data type

text

Date of Dose
Description

Date of Dose

Data type

date

Time of Dose
Description

Time of Dose

Data type

time

Treatment Confirmation
Description

Treatment Confirmation

Did the subject receive the correct treatment (e.g, treatment which the subject was assigned to) during this dosing interval?
Description

Did the subject receive the correct treatment (e.g, treatment which the subject was assigned to) during this dosing interval?

Data type

boolean

If NO, record reason(s)
Description

If NO, record reason(s)

Data type

text

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Similar models

Part 2: Repeat Dose Phase - Day 21 - Treatment confirmation

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Identifier
Item
Subject Identifier
integer
Item Group
Investigational Product
Item
Planned Timepoint
integer
Planned Timepoint
Code List
Planned Timepoint
CL Item
Day 20 AM (1)
CL Item
Day 20 AM (2)
CL Item
Day 20 PM (3)
CL Item
Day 20 PM (4)
Item
Investigational Product
text
Investigational Product
Code List
Investigational Product
CL Item
Dustasteride (1)
CL Item
Testosterone (2)
CL Item
Dustasteride (3)
CL Item
Testosterone (4)
Date of Dose
Item
Date of Dose
date
Time of Dose
Item
Time of Dose
time
Item Group
Treatment Confirmation
Did the subject receive the correct treatment (e.g, treatment which the subject was assigned to) during this dosing interval?
Item
Did the subject receive the correct treatment (e.g, treatment which the subject was assigned to) during this dosing interval?
boolean
If NO, record reason(s)
Item
text
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