ID
32389
Description
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
Keywords
Versions (5)
- 10/21/18 10/21/18 -
- 10/21/18 10/21/18 -
- 10/26/18 10/26/18 -
- 10/29/18 10/29/18 -
- 1/15/19 1/15/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 29, 2018
DOI
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License
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
Description
Pharmacokinetics - Blood
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0005767
Description
Time Relative to Dosing In brackets, the sample number according to the planned relative time is given; the first number indicates the period.
Data type
integer
Alias
- UMLS CUI [1]
- C0439564
Description
Date Sample Taken
Data type
date
Alias
- UMLS CUI [1]
- C1302413
Description
Date sample taken not applicable because sample missed or lost
Data type
text
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C1272460
Description
Actual Time
Data type
time
Measurement units
- Hr : Min
Alias
- UMLS CUI [1]
- C0040223
Description
3mL Sample Taken
Data type
boolean
Alias
- UMLS CUI [1]
- C1277698
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Vital signs: Date
Data type
date
Alias
- UMLS CUI [1]
- C2826644
Description
Vital signs: Planned relative time
Data type
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0439564
Description
Vital signs: Actual time
Data type
time
Measurement units
- Hr : Min
Alias
- UMLS CUI [1]
- C2826762
Description
Systolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Measurement units
- 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])