ID

32329

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)
  1. 10/17/18 10/17/18 -
  2. 10/19/18 10/19/18 -
  3. 10/26/18 10/26/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 26, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880

English

Eligibility Criteria

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Criteria
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Eligibility Question
Description

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
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
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Healthy males between 18 and 55 years of age, inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, ECGs and other tests.
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
Body weight > 50 kg (110 lbs) and Body mass index (BMI) between 19 and 34 kg/m2 where: BMI = (weight in kg)/(height in meters)^2
Description

Body weight and BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
Negative hepatitis B and C, and HIV tests.
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
Willing and able to give written informed consent, willing to participate in the full duration of the study, and able to understand and follow instructions related to study procedures.
Description

Written informed consent and willingness to participate

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Any clinically relevant abnormality identified on the screening or check-in examination/clinical labs or any other medical condition or circumstance making the volunteer unsuitable for participation in the study.
Description

Any medical contraindication to participation in the study

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1301624
Positive urine drug, alcohol or cotinine screen at check in or screening visits.
Description

Positive urine drug, alcohol or cotinine testing

Data type

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C1699505
UMLS CUI [3]
C1112219
History of regular alcohol consumption exceeding 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
Description

Recent regular alcohol consumption exceeding 14 drinks/week

Data type

boolean

Alias
UMLS CUI [1,1]
C0552479
UMLS CUI [1,2]
C0560579
Use of prescription or non-prescription drugs (other than acetaminophen at doses of <2 grams/day up until 48 hours of dosing) within seven days or 5 half-lives (whichever is longer) prior to Day 1 of Period 1 and throughout the study.
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
Use of vitamins and dietary/herbal supplements within 14 days prior to Day 1 of Period 1 and throughout the study.
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
Use of tobacco or nicotine-containing products 60 days prior to dosing.
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
Donation of 500 mL of blood within 56 days prior to dosing.
Description

Recent blood donation

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332185
Treatment with a new molecular entity (investigational drug) or any other trial during the previous 30 days or five half-lives, whichever is longer. A new molecular entity is defined as any compound not in Phase 3 (the washout is from last dose of study medication in the previous study until the first dose of study medication).
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
Back to the top of the page

Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: ODM
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Item
Did the subject meet all the entry criteria?
text
C1516637 (UMLS CUI [1])
Eligibility of the subject
Code List
Did the subject meet all the entry criteria?
CL Item
Yes ([Y])
CL Item
No ([N])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Males between 18 and 55 years of age, healthy as determined by their medical history, physical examination, laboratory studies, ECGs and other tests
Item
Healthy males between 18 and 55 years of age, inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, ECGs and other tests.
boolean
C0001779 (UMLS CUI [1])
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])
Body weight and BMI
Item
Body weight > 50 kg (110 lbs) and Body mass index (BMI) between 19 and 34 kg/m2 where: BMI = (weight in kg)/(height in meters)^2
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Negative hepatitis B and C, and HIV tests
Item
Negative hepatitis B and C, and HIV tests.
boolean
C1611173 (UMLS CUI [1])
C1619717 (UMLS CUI [2])
C0481430 (UMLS CUI [3])
Written informed consent and willingness to participate
Item
Willing and able to give written informed consent, willing to participate in the full duration of the study, and able to understand and follow instructions related to study procedures.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Any medical contraindication to participation in the study
Item
Any clinically relevant abnormality identified on the screening or check-in examination/clinical labs or any other medical condition or circumstance making the volunteer unsuitable for participation in the study.
boolean
C2348568 (UMLS CUI [1,1])
C1301624 (UMLS CUI [1,2])
Positive urine drug, alcohol or cotinine testing
Item
Positive urine drug, alcohol or cotinine screen at check in or screening visits.
boolean
C0743300 (UMLS CUI [1])
C1699505 (UMLS CUI [2])
C1112219 (UMLS CUI [3])
Recent regular alcohol consumption exceeding 14 drinks/week
Item
History of regular alcohol consumption exceeding 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
boolean
C0552479 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Recent use of prescription or non-prescription drugs, except for acetaminophen < 2 grams/day up until 48 hours of dosing
Item
Use of prescription or non-prescription drugs (other than acetaminophen at doses of <2 grams/day up until 48 hours of dosing) within seven days or 5 half-lives (whichever is longer) prior to Day 1 of Period 1 and throughout the study.
boolean
C0013227 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0332300 (UMLS CUI [1,3])
C0000970 (UMLS CUI [1,4])
Use of vitamins and dietary/herbal supplements
Item
Use of vitamins and dietary/herbal supplements within 14 days prior to Day 1 of Period 1 and throughout the study.
boolean
C0242295 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0042890 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Use of tobacco or nicotine-containing products
Item
Use of tobacco or nicotine-containing products 60 days prior to dosing.
boolean
C0543414 (UMLS CUI [1])
C1514468 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0028040 (UMLS CUI [2,3])
Recent blood donation
Item
Donation of 500 mL of blood within 56 days prior to dosing.
boolean
C0005794 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Recent treatment with another experimental drug and another study participation
Item
Treatment with a new molecular entity (investigational drug) or any other trial during the previous 30 days or five half-lives, whichever is longer. A new molecular entity is defined as any compound not in Phase 3 (the washout is from last dose of study medication in the previous study until the first dose of study medication).
boolean
C0332185 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial