ID
32127
Description
This ODM file contains the eligibility criteria. To be assessed at screening. 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 (3)
- 10/17/18 10/17/18 -
- 10/19/18 10/19/18 -
- 10/26/18 10/26/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 19, 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
Eligibility Criteria
- StudyEvent: ODM
Description
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Description
MONITOR DATA VALIDATION CHECK • Confirm that the subject is eligible to participate in the study and if not, that all the failed criteria have been marked. ]by [N]bn If No, ✔ all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if they failed any inclusion or exclusion criteria below.
Data type
text
Alias
- UMLS CUI [1]
- C1516637
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
Males between 18 and 55 years of age, healthy as determined by their medical history, physical examination, laboratory studies, ECGs and other tests
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
- UMLS CUI [2]
- C0086582
- UMLS CUI [3]
- C3898900
- UMLS CUI [4]
- C0262926
- UMLS CUI [5]
- C0031809
- UMLS CUI [6]
- C0681827
- UMLS CUI [7]
- C1623258
- UMLS CUI [8]
- C0205394
Description
Body weight and BMI
Data type
boolean
Alias
- UMLS CUI [1]
- C1305855
- UMLS CUI [2]
- C0005910
Description
Negative hepatitis B and C, and HIV tests
Data type
boolean
Alias
- UMLS CUI [1]
- C1611173
- UMLS CUI [2]
- C1619717
- UMLS CUI [3]
- C0481430
Description
Willing to give written informed consent
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0600109
- UMLS CUI [1,2]
- C0021430
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Description
Any medical contraindication to participation in the study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1301624
Description
Positive urine drug, alcohol or cotinine testing
Data type
boolean
Alias
- UMLS CUI [1]
- C0743300
- UMLS CUI [2]
- C1699505
- UMLS CUI [3]
- C1112219
Description
Recent regular alcohol consumption exceeding 14 drinks/week
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0552479
- UMLS CUI [1,2]
- C0560579
Description
Recent use of prescription or non-prescription drugs, except for acetaminophen < 2 grams/day up until 48 hours of dosing
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [1,3]
- C0332300
- UMLS CUI [1,4]
- C0000970
Description
Use of vitamins and dietary/herbal supplements
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0242295
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0042890
- UMLS CUI [2,2]
- C0332185
Description
Use of tobacco or nicotine-containing products
Data type
boolean
Alias
- UMLS CUI [1]
- C0543414
- UMLS CUI [2,1]
- C1514468
- UMLS CUI [2,2]
- C0332256
- UMLS CUI [2,3]
- C0028040
Description
Recent blood donation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005794
- UMLS CUI [1,2]
- C0332185
Description
Recent treatment with another experimental drug and another study participation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332185
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [2]
- C2348568
Similar models
Eligibility Criteria
- StudyEvent: ODM
C0086582 (UMLS CUI [2])
C3898900 (UMLS CUI [3])
C0262926 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
C0681827 (UMLS CUI [6])
C1623258 (UMLS CUI [7])
C0205394 (UMLS CUI [8])
C0005910 (UMLS CUI [2])
C1619717 (UMLS CUI [2])
C0481430 (UMLS CUI [3])
C0021430 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,2])
C1699505 (UMLS CUI [2])
C1112219 (UMLS CUI [3])
C0560579 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C0000970 (UMLS CUI [1,4])
C0332185 (UMLS CUI [1,2])
C0042890 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1514468 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0028040 (UMLS CUI [2,3])
C0332185 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])