ID

32327

Beschrijving

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

Trefwoorden

Versies (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 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

26 oktober 2018

DOI

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Licentie

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

Engels

Dosing 0 Form

1 Formulieren  
  1. StudyEvent: ODM
    1. Dosing 0 Form
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beschrijving

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Study Period
Beschrijving

Study Period

Datatype

integer

Alias
UMLS CUI [1]
C2347804
Investigational Product
Beschrijving

Investigational Product

Alias
UMLS CUI-1
C0304229
Treatment Type
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1]
C0087111
Dose
Beschrijving

Dose

Datatype

float

Maateenheden
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Date of Dose
Beschrijving

Date of Dose

Datatype

date

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

Time of Dose

Datatype

time

Maateenheden
  • Hr : Min
Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Hr : Min
Fasting
Beschrijving

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?
Beschrijving

If No, specify quantities and time of food consumption.

Datatype

text

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

Specification of quantities and time of food consumption

Datatype

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 Formulieren
  1. StudyEvent: ODM
    1. Dosing 0 Form
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
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