ID
32136
Description
This ODM file contains a form to document the results of the drug and alcohol screen, urine cotinine test, serology and hiv screen. 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 (1)
- 10/20/18 10/20/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 20, 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
Drug and Alcohol Screen, Urine Cotinine Test, Serology/HIV Screen
Description
Drug And Alcohol Screen Including Cotinine
Alias
- UMLS CUI-1
- C0373483
- UMLS CUI-2
- C3863708
- UMLS CUI-3
- C1697737
Description
Date sample taken
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0202304
- UMLS CUI [1,2]
- C1446409
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0002667
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0004745
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0005064
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0009170
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0001962
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0024808
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0025605
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0025627
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0376196
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0031381
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0202458
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0202363
Description
Serology / HIV Screen
Alias
- UMLS CUI-1
- C0459958
- UMLS CUI-3
- C0036743
Description
Date Sample Taken
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0149709
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C0281863
Description
If positive, exclude subject from the study.
Data type
integer
Alias
- UMLS CUI [1]
- C3714540
Similar models
Drug and Alcohol Screen, Urine Cotinine Test, Serology/HIV Screen
C3863708 (UMLS CUI-2)
C1697737 (UMLS CUI-3)