ID
32327
Description
This ODM file contains a form for the documention required at the dosing 0 timepoint. 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 (4)
- 10/21/18 10/21/18 -
- 10/21/18 10/21/18 -
- 10/21/18 10/21/18 -
- 10/26/18 10/26/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 26, 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
Dosing 0 Form
- StudyEvent: ODM
Description
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Description
Treatment A = Dutasteride 0.5 mg Softgel capsule (Reference) Treatment B = Dutasteride 0.5mg Softgel capsule containing 300mg Capmul Treatment C = Dutasteride 0.5mg Softgel capsule containing 100mg Capmul
Data type
text
Alias
- UMLS CUI [1]
- C0087111
Description
Dose
Data type
float
Measurement units
- mg
Alias
- UMLS CUI [1]
- C3174092
Description
Date of Dose
Data type
date
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Description
Time of Dose
Data type
time
Measurement units
- Hr : Min
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0040223
Description
Fasting
Alias
- UMLS CUI-1
- C0015663
Description
If No, specify quantities and time of food consumption.
Data type
text
Alias
- UMLS CUI [1,1]
- C0015663
- UMLS CUI [1,2]
- C0178602
Description
Specification of quantities and time of food consumption
Data type
text
Alias
- UMLS CUI [1,1]
- C2983605
- UMLS CUI [1,2]
- C1265611
- UMLS CUI [2,1]
- C2983605
- UMLS CUI [2,2]
- C0040223
Similar models
Dosing 0 Form
- StudyEvent: ODM
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
C2983605 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])