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
Mots-clés
Versions (2)
- 20/10/2018 20/10/2018 -
- 26/10/2018 26/10/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
26 octobre 2018
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880
Check-In Form
- StudyEvent: ODM
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Sitting
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Sitting
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Sitting
Type de données
integer
Unités de mesure
- beats/minute
Alias
- UMLS CUI [1]
- C0018810
Description
Randomisation Number (Only Period 1)
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Description
Drug And Alcohol Screen Including Cotinine
Alias
- UMLS CUI-1
- C0373483
- UMLS CUI-2
- C3863708
- UMLS CUI-3
- C1697737
Description
Date Sample Taken
Type de données
date
Alias
- UMLS CUI [1]
- C1302413
Description
If positive, exclude subject from the study
Type de données
integer
Alias
- UMLS CUI [1]
- C0001948
Description
If positive, exclude subject from the study
Type de données
integer
Alias
- UMLS CUI [1]
- C0002667
Description
If positive, exclude subject from the study
Type de données
integer
Alias
- UMLS CUI [1]
- C0004745
Description
If positive, exclude subject from the study
Type de données
integer
Alias
- UMLS CUI [1]
- C0005064
Description
If positive, exclude subject from the study
Type de données
integer
Alias
- UMLS CUI [1]
- C0009170
Description
If positive, exclude subject from the study
Type de données
integer
Alias
- UMLS CUI [1]
- C0001962
Description
If positive, exclude subject from the study
Type de données
integer
Alias
- UMLS CUI [1]
- C0024808
Description
If positive, exclude subject from the study
Type de données
integer
Alias
- UMLS CUI [1]
- C0025605
Description
If positive, exclude subject from the study
Type de données
integer
Alias
- UMLS CUI [1]
- C0025627
Description
If positive, exclude subject from the study
Type de données
integer
Alias
- UMLS CUI [1]
- C0376196
Description
If positive, exclude subject from the study
Type de données
integer
Alias
- UMLS CUI [1]
- C0031381
Description
If positive, exclude subject from the study
Type de données
integer
Alias
- UMLS CUI [1]
- C0202458
Description
If positive, exclude subject from the study
Type de données
integer
Alias
- UMLS CUI [1]
- C0202363
Similar models
Check-In Form
- StudyEvent: ODM
C0237753 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])
C3863708 (UMLS CUI-2)
C1697737 (UMLS CUI-3)