ID
32326
Beschreibung
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
Stichworte
Versionen (2)
- 20.10.18 20.10.18 -
- 26.10.18 26.10.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
26. Oktober 2018
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880
Check-In Form
- StudyEvent: ODM
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Sitting
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Sitting
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Sitting
Datentyp
integer
Maßeinheiten
- beats/minute
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Randomisation Number (Only Period 1)
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Beschreibung
Drug And Alcohol Screen Including Cotinine
Alias
- UMLS CUI-1
- C0373483
- UMLS CUI-2
- C3863708
- UMLS CUI-3
- C1697737
Beschreibung
Date Sample Taken
Datentyp
date
Alias
- UMLS CUI [1]
- C1302413
Beschreibung
If positive, exclude subject from the study
Datentyp
integer
Alias
- UMLS CUI [1]
- C0001948
Beschreibung
If positive, exclude subject from the study
Datentyp
integer
Alias
- UMLS CUI [1]
- C0002667
Beschreibung
If positive, exclude subject from the study
Datentyp
integer
Alias
- UMLS CUI [1]
- C0004745
Beschreibung
If positive, exclude subject from the study
Datentyp
integer
Alias
- UMLS CUI [1]
- C0005064
Beschreibung
If positive, exclude subject from the study
Datentyp
integer
Alias
- UMLS CUI [1]
- C0009170
Beschreibung
If positive, exclude subject from the study
Datentyp
integer
Alias
- UMLS CUI [1]
- C0001962
Beschreibung
If positive, exclude subject from the study
Datentyp
integer
Alias
- UMLS CUI [1]
- C0024808
Beschreibung
If positive, exclude subject from the study
Datentyp
integer
Alias
- UMLS CUI [1]
- C0025605
Beschreibung
If positive, exclude subject from the study
Datentyp
integer
Alias
- UMLS CUI [1]
- C0025627
Beschreibung
If positive, exclude subject from the study
Datentyp
integer
Alias
- UMLS CUI [1]
- C0376196
Beschreibung
If positive, exclude subject from the study
Datentyp
integer
Alias
- UMLS CUI [1]
- C0031381
Beschreibung
If positive, exclude subject from the study
Datentyp
integer
Alias
- UMLS CUI [1]
- C0202458
Beschreibung
If positive, exclude subject from the study
Datentyp
integer
Alias
- UMLS CUI [1]
- C0202363
Ähnliche Modelle
Check-In Form
- StudyEvent: ODM
C0237753 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])
C3863708 (UMLS CUI-2)
C1697737 (UMLS CUI-3)