ID

32267

Beschrijving

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

Trefwoorden

  1. 25-10-18 25-10-18 -
  2. 17-01-19 17-01-19 -
  3. 04-03-19 04-03-19 -
Houder van rechten

GSK group of companies

Geüploaded op

25 oktober 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

Part 2: Repeat Dose Phase - Day 26 - Clinical Chemistry Result

Administrative data
Beschrijving

Administrative data

Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

24HR Local Laboratory Result Data
Beschrijving

24HR Local Laboratory Result Data

Date sample taken
Beschrijving

Date sample taken

Datatype

date

Time sample taken
Beschrijving

Time sample taken

Datatype

time

Has the subject fasted?
Beschrijving

Has the subject fasted?

Datatype

boolean

Clinical Chemistry Test
Beschrijving

Clinical Chemistry Test

TSH
Beschrijving

TSH

Datatype

float

Maateenheden
  • U/ml
U/ml
T4
Beschrijving

T4

Datatype

float

Maateenheden
  • g/dL
g/dL
Triglycerides
Beschrijving

Triglycerides

Datatype

float

HDL
Beschrijving

HDL

Datatype

float

Maateenheden
  • mg/dL
mg/dL
Calculated LDL
Beschrijving

Calculated LDL

Datatype

float

Maateenheden
  • mmol/L
mmol/L
Total Cholesterol
Beschrijving

Total Cholesterol

Datatype

float

If the laboratory results meet the protocol definition of an adverse evnt, record the details an the NON-Serious Adverse Events page or Serious Adverse Event page.
Beschrijving

If the laboratory results meet the protocol definition of an adverse evnt, record the details an the NON-Serious Adverse Events page or Serious Adverse Event page.

Datatype

text

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Part 2: Repeat Dose Phase - Day 26 - Clinical Chemistry Result

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Subject Identifier
Item
Subject Identifier
integer
Item Group
24HR Local Laboratory Result Data
Date sample taken
Item
Date sample taken
date
Time sample taken
Item
Time sample taken
time
Has the subject fasted?
Item
Has the subject fasted?
boolean
Item Group
Clinical Chemistry Test
TSH
Item
TSH
float
T4
Item
T4
float
Triglycerides
Item
Triglycerides
float
HDL
Item
HDL
float
Calculated LDL
Item
Calculated LDL
float
Total Cholesterol
Item
Total Cholesterol
float
If the laboratory results meet the protocol definition of an adverse evnt, record the details an the NON-Serious Adverse Events page or Serious Adverse Event page.
Item
If the laboratory results meet the protocol definition of an adverse evnt, record the details an the NON-Serious Adverse Events page or Serious Adverse Event page.
text

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