ID

32390

Beschrijving

This ODM file contains a form for the documention required at the pre-dose visits. 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 (2)
  1. 26-10-18 26-10-18 -
  2. 29-10-18 29-10-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

29 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

Pre-Dose Form

1 Formulieren  
  1. StudyEvent: ODM
    1. Pre-Dose 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
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Blood pressure (Systolic)
Beschrijving

Sitting

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure (Diastolic)
Beschrijving

Sitting

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschrijving

Sitting

Datatype

integer

Maateenheden
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
Pharmacokinetics - Blood
Beschrijving

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0005767
Planned Relative Time
Beschrijving

Time Relative to Dosing

Datatype

integer

Alias
UMLS CUI [1]
C0439564
Date Sample Taken
Beschrijving

Date Sample Taken

Datatype

date

Alias
UMLS CUI [1]
C1302413
Actual Time
Beschrijving

Actual Time

Datatype

time

Maateenheden
  • Hr : Min
Alias
UMLS CUI [1]
C0040223
Hr : Min
3mL Sample Taken
Beschrijving

3mL Sample Taken

Datatype

boolean

Alias
UMLS CUI [1]
C1277698
Sample Number
Beschrijving

The sample number 100 is to be used in period 1, 200 in period 2 and 300 in period 3

Datatype

integer

Alias
UMLS CUI [1]
C1299222
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Similar models

Pre-Dose Form

1 Formulieren
  1. StudyEvent: ODM
    1. Pre-Dose 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
Vital Signs
C0518766 (UMLS CUI-1)
Systolic blood pressure
Item
Blood pressure (Systolic)
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood pressure (Diastolic)
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Pharmacokinetics - Blood
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time of Dosage
Code List
Planned Relative Time
CL Item
1. Pre-Dose (1)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
3mL Sample Taken
Item
3mL Sample Taken
boolean
C1277698 (UMLS CUI [1])
Item
Sample Number
integer
C1299222 (UMLS CUI [1])
Sample Number
Code List
Sample Number
CL Item
100  (100)
CL Item
200 (200)
CL Item
300 (300)
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