ID

32327

Beskrivning

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

Nyckelord

Versioner (4)
  1. 2018-10-21 2018-10-21 -
  2. 2018-10-21 2018-10-21 -
  3. 2018-10-21 2018-10-21 -
  4. 2018-10-26 2018-10-26 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

26 oktober 2018

DOI

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Licens

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

Engelsk

Dosing 0 Form

1 Formulär  
  1. StudyEvent: ODM
    1. Dosing 0 Form
Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Beskrivning

Subject Identifier

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Study Period
Beskrivning

Study Period

Datatyp

integer

Alias
UMLS CUI [1]
C2347804
Investigational Product
Beskrivning

Investigational Product

Alias
UMLS CUI-1
C0304229
Treatment Type
Beskrivning

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

Datatyp

text

Alias
UMLS CUI [1]
C0087111
Dose
Beskrivning

Dose

Datatyp

float

Måttenheter
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Date of Dose
Beskrivning

Date of Dose

Datatyp

date

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

Time of Dose

Datatyp

time

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

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?
Beskrivning

If No, specify quantities and time of food consumption.

Datatyp

text

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

Specification of quantities and time of food consumption

Datatyp

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 Formulär
  1. StudyEvent: ODM
    1. Dosing 0 Form
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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