ID
34175
Beschrijving
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
Trefwoorden
Versies (5)
- 21-10-18 21-10-18 -
- 21-10-18 21-10-18 -
- 26-10-18 26-10-18 -
- 29-10-18 29-10-18 -
- 15-01-19 15-01-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
15 januari 2019
DOI
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Licentie
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
Beschrijving
Pharmacokinetics - Blood
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0005767
Beschrijving
Time Relative to Dosing In brackets, the sample number according to the planned relative time is given; the first number indicates the period.
Datatype
text
Alias
- UMLS CUI [1]
- C0439564
Beschrijving
Date Sample Taken
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Date sample taken not applicable because sample missed or lost
Datatype
text
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C1272460
Beschrijving
Actual Time
Datatype
time
Maateenheden
- Hr : Min
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
3mL Sample Taken
Datatype
boolean
Alias
- UMLS CUI [1]
- C1277698
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Vital signs: Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826644
Beschrijving
Vital signs: Planned relative time
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
Beschrijving
Vital signs: Actual time
Datatype
time
Maateenheden
- Hr : Min
Alias
- UMLS CUI [1]
- C2826762
Beschrijving
Systolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic blood pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- 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])