ID
32329
Beschrijving
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
Trefwoorden
Versies (3)
- 17-10-18 17-10-18 -
- 19-10-18 19-10-18 -
- 26-10-18 26-10-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
26 oktober 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880
Eligibility Criteria
- StudyEvent: ODM
Beschrijving
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beschrijving
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.
Datatype
text
Alias
- UMLS CUI [1]
- C1516637
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
Males between 18 and 55 years of age, healthy as determined by their medical history, physical examination, laboratory studies, ECGs and other tests
Datatype
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
Beschrijving
Body weight and BMI
Datatype
boolean
Alias
- UMLS CUI [1]
- C1305855
- UMLS CUI [2]
- C0005910
Beschrijving
Negative hepatitis B and C, and HIV tests
Datatype
boolean
Alias
- UMLS CUI [1]
- C1611173
- UMLS CUI [2]
- C1619717
- UMLS CUI [3]
- C0481430
Beschrijving
Written informed consent and willingness to participate
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
- UMLS CUI [2]
- C1321605
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Any medical contraindication to participation in the study
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C1301624
Beschrijving
Positive urine drug, alcohol or cotinine testing
Datatype
boolean
Alias
- UMLS CUI [1]
- C0743300
- UMLS CUI [2]
- C1699505
- UMLS CUI [3]
- C1112219
Beschrijving
Recent regular alcohol consumption exceeding 14 drinks/week
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0552479
- UMLS CUI [1,2]
- C0560579
Beschrijving
Recent use of prescription or non-prescription drugs, except for acetaminophen < 2 grams/day up until 48 hours of dosing
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [1,3]
- C0332300
- UMLS CUI [1,4]
- C0000970
Beschrijving
Use of vitamins and dietary/herbal supplements
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0242295
- UMLS CUI [1,2]
- C0332185
- UMLS CUI [2,1]
- C0042890
- UMLS CUI [2,2]
- C0332185
Beschrijving
Use of tobacco or nicotine-containing products
Datatype
boolean
Alias
- UMLS CUI [1]
- C0543414
- UMLS CUI [2,1]
- C1514468
- UMLS CUI [2,2]
- C0332256
- UMLS CUI [2,3]
- C0028040
Beschrijving
Recent blood donation
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005794
- UMLS CUI [1,2]
- C0332185
Beschrijving
Recent treatment with another experimental drug and another study participation
Datatype
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])
C1321605 (UMLS CUI [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])