ID
32326
Beschrijving
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
Trefwoorden
Versies (2)
- 20-10-18 20-10-18 -
- 26-10-18 26-10-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
26 oktober 2018
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880
Check-In Form
- StudyEvent: ODM
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Sitting
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Sitting
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Sitting
Datatype
integer
Maateenheden
- beats/minute
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Randomisation Number (Only Period 1)
Alias
- UMLS CUI-1
- C0034656
- UMLS CUI-2
- C0237753
Beschrijving
Drug And Alcohol Screen Including Cotinine
Alias
- UMLS CUI-1
- C0373483
- UMLS CUI-2
- C3863708
- UMLS CUI-3
- C1697737
Beschrijving
Date Sample Taken
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
If positive, exclude subject from the study
Datatype
integer
Alias
- UMLS CUI [1]
- C0001948
Beschrijving
If positive, exclude subject from the study
Datatype
integer
Alias
- UMLS CUI [1]
- C0002667
Beschrijving
If positive, exclude subject from the study
Datatype
integer
Alias
- UMLS CUI [1]
- C0004745
Beschrijving
If positive, exclude subject from the study
Datatype
integer
Alias
- UMLS CUI [1]
- C0005064
Beschrijving
If positive, exclude subject from the study
Datatype
integer
Alias
- UMLS CUI [1]
- C0009170
Beschrijving
If positive, exclude subject from the study
Datatype
integer
Alias
- UMLS CUI [1]
- C0001962
Beschrijving
If positive, exclude subject from the study
Datatype
integer
Alias
- UMLS CUI [1]
- C0024808
Beschrijving
If positive, exclude subject from the study
Datatype
integer
Alias
- UMLS CUI [1]
- C0025605
Beschrijving
If positive, exclude subject from the study
Datatype
integer
Alias
- UMLS CUI [1]
- C0025627
Beschrijving
If positive, exclude subject from the study
Datatype
integer
Alias
- UMLS CUI [1]
- C0376196
Beschrijving
If positive, exclude subject from the study
Datatype
integer
Alias
- UMLS CUI [1]
- C0031381
Beschrijving
If positive, exclude subject from the study
Datatype
integer
Alias
- UMLS CUI [1]
- C0202458
Beschrijving
If positive, exclude subject from the study
Datatype
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)