ID

32327

Descripción

This ODM file contains a form for the documention required at the dosing 0 timepoint. Study ID: 103880 Clinical Study ID: ARI103880 Study Title: An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Duagen,Zytefor,Avolve,Avodart,Avidart,Zyfetor; Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Prostatic Hyperplasia

Palabras clave

Versiones (4)
  1. 21/10/18 21/10/18 -
  2. 21/10/18 21/10/18 -
  3. 21/10/18 21/10/18 -
  4. 26/10/18 26/10/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

26 de octubre de 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880

Inglés

Dosing 0 Form

1 formularios  
  1. StudyEvent: ODM
    1. Dosing 0 Form
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Descripción

Visit Date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Study Period
Descripción

Study Period

Tipo de datos

integer

Alias
UMLS CUI [1]
C2347804
Investigational Product
Descripción

Investigational Product

Alias
UMLS CUI-1
C0304229
Treatment Type
Descripción

Treatment A = Dutasteride 0.5 mg Softgel capsule (Reference) Treatment B = Dutasteride 0.5mg Softgel capsule containing 300mg Capmul Treatment C = Dutasteride 0.5mg Softgel capsule containing 100mg Capmul

Tipo de datos

text

Alias
UMLS CUI [1]
C0087111
Dose
Descripción

Dose

Tipo de datos

float

Unidades de medida
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Date of Dose
Descripción

Date of Dose

Tipo de datos

date

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

Time of Dose

Tipo de datos

time

Unidades de medida
  • Hr : Min
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Hr : Min
Fasting
Descripción

Fasting

Alias
UMLS CUI-1
C0015663
Was the subject fasting (except for water up to 1 hour prior to and 1 hour after) for at least 8 hours prior to dosing and 4 hours after dosing?
Descripción

If No, specify quantities and time of food consumption.

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0015663
UMLS CUI [1,2]
C0178602
If No, specify quantities and time of food consumption.
Descripción

Specification of quantities and time of food consumption

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2983605
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C2983605
UMLS CUI [2,2]
C0040223
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Similar models

Dosing 0 Form

1 formularios
  1. StudyEvent: ODM
    1. Dosing 0 Form
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item
Study Period
integer
C2347804 (UMLS CUI [1])
Visit Type
Code List
Study Period
CL Item
Period 1 (1)
CL Item
Period 2 (2)
CL Item
Period 3 (3)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Treatment Type
text
C0087111 (UMLS CUI [1])
Treatment Type
Code List
Treatment Type
CL Item
A (A)
CL Item
B (B)
CL Item
C (C)
Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item Group
Fasting
C0015663 (UMLS CUI-1)
Item
Was the subject fasting (except for water up to 1 hour prior to and 1 hour after) for at least 8 hours prior to dosing and 4 hours after dosing?
text
C0015663 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Fasting prior to and after dosing
Code List
Was the subject fasting (except for water up to 1 hour prior to and 1 hour after) for at least 8 hours prior to dosing and 4 hours after dosing?
CL Item
Yes (Y)
CL Item
No (N)
Specification of quantities and time of food consumption
Item
If No, specify quantities and time of food consumption.
text
C2983605 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2983605 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
Volver a la parte superior de la página 

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