ID
32129
Beschrijving
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
Trefwoorden
Versies (2)
- 19-10-18 19-10-18 -
- 26-10-18 26-10-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
19 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
Demography
- StudyEvent: ODM
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
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
Datatype
text
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C1515945
Beschrijving
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)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C4540996
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C1556094
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C0238697
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C1513907
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C0238604
- UMLS CUI [2]
- C0026068
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C0043157
Similar models
Demography
- StudyEvent: ODM
C0027567 (UMLS CUI [2])
C1519427 (UMLS CUI [2])
C0026068 (UMLS CUI [2])