ID
34175
Beskrivning
This ODM file contains a form for the documention required at the 0.5 - 72 hours timepoints. 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
Nyckelord
Versioner (5)
- 2018-10-21 2018-10-21 -
- 2018-10-21 2018-10-21 -
- 2018-10-26 2018-10-26 -
- 2018-10-29 2018-10-29 -
- 2019-01-15 2019-01-15 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
15 januari 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880
0.5 - 72 Hour Timepoints Form
- StudyEvent: ODM
Beskrivning
Pharmacokinetics - Blood
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0005767
Beskrivning
Time Relative to Dosing In brackets, the sample number according to the planned relative time is given; the first number indicates the period.
Datatyp
text
Alias
- UMLS CUI [1]
- C0439564
Beskrivning
Date Sample Taken
Datatyp
date
Alias
- UMLS CUI [1]
- C1302413
Beskrivning
Date sample taken not applicable because sample missed or lost
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C1272460
Beskrivning
Actual Time
Datatyp
time
Måttenheter
- Hr : Min
Alias
- UMLS CUI [1]
- C0040223
Beskrivning
3mL Sample Taken
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1277698
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Vital signs: Date
Datatyp
date
Alias
- UMLS CUI [1]
- C2826644
Beskrivning
Vital signs: Planned relative time
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
Beskrivning
Vital signs: Actual time
Datatyp
time
Måttenheter
- Hr : Min
Alias
- UMLS CUI [1]
- C2826762
Beskrivning
Systolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic blood pressure
Datatyp
integer
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- beats/minute
Alias
- UMLS CUI [1]
- C0018810
Similar models
0.5 - 72 Hour Timepoints Form
- StudyEvent: ODM
C0005767 (UMLS CUI-2)
C1272460 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,2])