ID

32326

Description

This ODM file contains a form for the documention required at the check-in 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

Keywords

Versions (2)
  1. 10/20/18 10/20/18 -
  2. 10/26/18 10/26/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 26, 2018

DOI

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License

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

English

Check-In Form

1 forms  
  1. StudyEvent: ODM
    1. Check-In Form
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Study Period
Description

Study Period

Data type

integer

Alias
UMLS CUI [1]
C2347804
Vital Signs
Description

Vital Signs

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

Sitting

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure (Diastolic)
Description

Sitting

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Sitting

Data type

integer

Measurement units
  • beats/minute
Alias
UMLS CUI [1]
C0018810
beats/minute
Randomisation Number (Only Period 1)
Description

Randomisation Number (Only Period 1)

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0237753
Record randomisation number.
Description

Randomisation number

Data type

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Drug And Alcohol Screen Including Cotinine
Description

Drug And Alcohol Screen Including Cotinine

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C3863708
UMLS CUI-3
C1697737
Date Sample Taken
Description

Date Sample Taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Alcohol
Description

If positive, exclude subject from the study

Data type

integer

Alias
UMLS CUI [1]
C0001948
Amphetamines
Description

If positive, exclude subject from the study

Data type

integer

Alias
UMLS CUI [1]
C0002667
Barbiturates
Description

If positive, exclude subject from the study

Data type

integer

Alias
UMLS CUI [1]
C0004745
Benzodiazepines
Description

If positive, exclude subject from the study

Data type

integer

Alias
UMLS CUI [1]
C0005064
Cocaine Metabolite
Description

If positive, exclude subject from the study

Data type

integer

Alias
UMLS CUI [1]
C0009170
Ethanol
Description

If positive, exclude subject from the study

Data type

integer

Alias
UMLS CUI [1]
C0001962
Marijuana
Description

If positive, exclude subject from the study

Data type

integer

Alias
UMLS CUI [1]
C0024808
Methadone
Description

If positive, exclude subject from the study

Data type

integer

Alias
UMLS CUI [1]
C0025605
Methaqualone
Description

If positive, exclude subject from the study

Data type

integer

Alias
UMLS CUI [1]
C0025627
Opiates
Description

If positive, exclude subject from the study

Data type

integer

Alias
UMLS CUI [1]
C0376196
Phencyclidine
Description

If positive, exclude subject from the study

Data type

integer

Alias
UMLS CUI [1]
C0031381
Propoxyphene
Description

If positive, exclude subject from the study

Data type

integer

Alias
UMLS CUI [1]
C0202458
Cotinine
Description

If positive, exclude subject from the study

Data type

integer

Alias
UMLS CUI [1]
C0202363
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Similar models

Check-In Form

1 forms
  1. StudyEvent: ODM
    1. Check-In Form
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Randomisation Number (Only Period 1)
C0034656 (UMLS CUI-1)
C0237753 (UMLS CUI-2)
Randomisation number
Item
Record randomisation number.
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Item Group
Drug And Alcohol Screen Including Cotinine
C0373483 (UMLS CUI-1)
C3863708 (UMLS CUI-2)
C1697737 (UMLS CUI-3)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Item
Alcohol
integer
C0001948 (UMLS CUI [1])
Alcohol
Code List
Alcohol
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
integer
C0002667 (UMLS CUI [1])
Amphetamines
Code List
Amphetamines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Barbiturates
integer
C0004745 (UMLS CUI [1])
Barbiturates
Code List
Barbiturates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
integer
C0005064 (UMLS CUI [1])
Benzodiazepines
Code List
Benzodiazepines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cocaine Metabolite
integer
C0009170 (UMLS CUI [1])
Cocaine Metabolite
Code List
Cocaine Metabolite
CL Item
Positive (1)
CL Item
Negative (2)
Item
Ethanol
integer
C0001962 (UMLS CUI [1])
Ethanol
Code List
Ethanol
CL Item
Positive (1)
CL Item
Negative (2)
Item
Marijuana
integer
C0024808 (UMLS CUI [1])
Marijuana
Code List
Marijuana
CL Item
Positive (1)
CL Item
Negative (2)
Item
Methadone
integer
C0025605 (UMLS CUI [1])
Methadone
Code List
Methadone
CL Item
Positive (1)
CL Item
Negative (2)
Item
Methaqualone
integer
C0025627 (UMLS CUI [1])
Methaqualone
Code List
Methaqualone
CL Item
Positive (1)
CL Item
Negative (2)
Item
Opiates
integer
C0376196 (UMLS CUI [1])
Opiates
Code List
Opiates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Phencyclidine
integer
C0031381 (UMLS CUI [1])
Phencyclidine
Code List
Phencyclidine
CL Item
Positive (1)
CL Item
Negative (2)
Item
Propoxyphene
integer
C0202458 (UMLS CUI [1])
Propoxyphene
Code List
Propoxyphene
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cotinine
integer
C0202363 (UMLS CUI [1])
Cotinine
Code List
Cotinine
CL Item
Positive (1)
CL Item
Negative (2)
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