ID

35407

Descripción

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

Palabras clave

  1. 24/10/18 24/10/18 -
  2. 14/1/19 14/1/19 -
  3. 4/3/19 4/3/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

4 de marzo de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0

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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218

Part 2 - Treatment Period Day 19 - Investigational Product/Treatment Confirmation

Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Descripción

Clinical Trial Subject Unique Identifier

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Investigational Product
Descripción

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned Timepoint
Descripción

Experimental Drug, Timepoint, Planned

Tipo de datos

text

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

Experimental Drug

Tipo de datos

text

Alias
UMLS CUI [1]
C0304229
Date of Dose
Descripción

Experimental Drug, Dosage, Date in time

Tipo de datos

date

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

Experimental Drug, Dosage, Time

Tipo de datos

time

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

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?
Descripción

Therapeutic Procedure, Correct

Tipo de datos

boolean

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

Therapeutic Procedure, Wrong, Indication

Tipo de datos

text

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

Similar models

Part 2 - Treatment Period Day 19 - Investigational Product/Treatment Confirmation

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Code List
Planned Timepoint
CL Item
Day 19 AM (1)
CL Item
Day 19 PM (2)
Item
Investigational Product
text
C0304229 (UMLS CUI [1])
Code List
Investigational Product
CL Item
Dustasteride (1)
CL Item
Dustasteride (2)
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])

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