ID
32129
Description
This ODM file contains a form to document the demography of the subject. To be assessed at screening. 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)
- 10/19/18 10/19/18 -
- 10/26/18 10/26/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 19, 2018
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880
Demography
- StudyEvent: ODM
Description
Demography
Alias
- UMLS CUI-1
- C0011298
Description
Date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Data type
text
Alias
- UMLS CUI [1]
- C0079399
Description
ETHNICITY • Hispanic or Latino A person of Cuban, Mexican, Puerto Rican, South American or other Spanish culture or origin, regardless of race Note: If the subject does not meet the definition above, ✔ Not Hispanic or Latino. • Not Hispanic or Latino Neither Hispanic or Latino
Data type
text
Alias
- UMLS CUI [1]
- C0015031
Description
The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to ✔ multiple boxes. A person having origins in any of the black racial groups of Africa
Data type
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Description
The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to ✔ multiple boxes. A person having origins in any of the original peoples of North and South America (including Central America) and who maintains tribal affiliation or community attachment
Data type
boolean
Alias
- UMLS CUI [1]
- C1515945
Description
The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to ✔ multiple boxes. A person having origins in Central Asia and Indian Subcontinent (India, Pakistan, Bangladesh and Sri Lanka)
Data type
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Description
The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to ✔ multiple boxes. A person having origins in China, Korea
Data type
boolean
Alias
- UMLS CUI [1]
- C4540996
Description
The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to ✔ multiple boxes. A person having origins in Japan
Data type
boolean
Alias
- UMLS CUI [1]
- C1556094
Description
The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to ✔ multiple boxes. A person having origins in Malaysia, the Philippines, Indonesia, Thailand, Vietnam, Laos, Burma or Cambodia
Data type
boolean
Alias
- UMLS CUI [1]
- C0238697
Description
The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to ✔ multiple boxes. A person having origins in any of the original peoples of Hawaii, Guam, Samoa or other Pacific Islands, Australia (Aborigines), Papua New Guinea, New Zealand, Marshalls and other island groups west and south of Japan
Data type
boolean
Alias
- UMLS CUI [1]
- C1513907
Description
The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to ✔ multiple boxes. A person having origins in any of the original peoples of Middle East or North Africa
Data type
boolean
Alias
- UMLS CUI [1]
- C0238604
- UMLS CUI [2]
- C0026068
Description
The racial groups below are based on the FDA and ICH Guidelines. Note: In order to provide for all eventualities, it is permissible to ✔ multiple boxes. A person having origins in any of the original peoples of Europe
Data type
boolean
Alias
- UMLS CUI [1]
- C0043157
Similar models
Demography
- StudyEvent: ODM
C0027567 (UMLS CUI [2])
C1519427 (UMLS CUI [2])
C0026068 (UMLS CUI [2])