ID

35434

Beskrivning

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

Nyckelord

Versioner (3)
  1. 2018-10-25 2018-10-25 -
  2. 2019-01-19 2019-01-19 -
  3. 2019-03-04 2019-03-04 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

4 mars 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

Engelsk

Part 2 - Repeat Dose Phase Day 26 - Investigational Product/Treatment Confirmation

1 Formulär  
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beskrivning

Clinical Trial Subject Unique Identifier

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Investigational Product
Beskrivning

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned Timepoint
Beskrivning

Experimental Drug, Timepoint, Planned

Datatyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2348792
UMLS CUI [1,3]
C1301732
Investigational Product
Beskrivning

Experimental Drug

Datatyp

text

Alias
UMLS CUI [1]
C0304229
Date of Dose
Beskrivning

Experimental Drug, Dosage, Date in time

Datatyp

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dose
Beskrivning

Experimental Drug, Dosage, Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Treatment Confirmation
Beskrivning

Treatment Confirmation

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0750484
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
Beskrivning

Therapeutic Procedure, Correct

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2349182
If No, record reason(s)
Beskrivning

Therapeutic Procedure, Wrong, Indication

Datatyp

text

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C3146298
Tillbaka till toppen

Similar models

Part 2 - Repeat Dose Phase Day 26 - Investigational Product/Treatment Confirmation

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Planned Timepoint
text
C0304229 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Experimental Drug, Timepoint, Planned
Code List
Planned Timepoint
CL Item
Day 26 AM (1)
CL Item
Day 26 AM (2)
CL Item
Day 26 PM (3)
CL Item
Day 26 PM (4)
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Experimental Drug, Timepoint, Planned
Code List
Investigational Product
CL Item
Dustasteride (1)
CL Item
Testosterone (2)
CL Item
Dustasteride (3)
CL Item
Testosterone (4)
Experimental Drug, Dosage, Date in time
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Experimental Drug, Dosage, Time
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Treatment Confirmation
C0087111 (UMLS CUI-1)
C0750484 (UMLS CUI-2)
Therapeutic Procedure, Correct
Item
Did the subject receive the correct treatment (e.g. treatment which the subject was assigned to) during this dosing interval?
boolean
C0087111 (UMLS CUI [1,1])
C2349182 (UMLS CUI [1,2])
Therapeutic Procedure, Wrong, Indication
Item
If No, record reason(s)
text
C0087111 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,3])
Tillbaka till toppen 

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