ID

32136

Description

This ODM file contains a form to document the results of the drug and alcohol screen, urine cotinine test, serology and hiv screen. 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 (1)
  1. 10/20/18 10/20/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 20, 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

English

Drug and Alcohol Screen, Urine Cotinine Test, Serology/HIV Screen

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Drug And Alcohol Screen Including Cotinine
Description

Drug And Alcohol Screen Including Cotinine

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C3863708
UMLS CUI-3
C1697737
Date sample taken
Description

Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Alcohol
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C1446409
Amphetamines
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0002667
Barbiturates
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0004745
Benzodiazepines
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0005064
Cocaine Metabolite
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0009170
Ethanol
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0001962
Marijuana
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0024808
Methadone
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0025605
Methaqualone
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0025627
Opiates
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0376196
Phencyclidine
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0031381
Propoxyphene
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0202458
Cotinine
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0202363
Serology / HIV Screen
Description

Serology / HIV Screen

Alias
UMLS CUI-1
C0459958
UMLS CUI-3
C0036743
Date Sample Taken
Description

Date Sample Taken

Data type

date

Alias
UMLS CUI [1]
C1302413
Hepatitis B Surface Antigen
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0149709
Hepatitis C Antibody
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C0281863
HIV Antibody
Description

If positive, exclude subject from the study.

Data type

integer

Alias
UMLS CUI [1]
C3714540
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Similar models

Drug and Alcohol Screen, Urine Cotinine Test, Serology/HIV Screen

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Drug And Alcohol Screen Including Cotinine
C0373483 (UMLS CUI-1)
C3863708 (UMLS CUI-2)
C1697737 (UMLS CUI-3)
Date sample taken
Item
Date sample taken
date
C1302413 (UMLS CUI [1])
Item
Alcohol
integer
C0202304 (UMLS CUI [1,1])
C1446409 (UMLS CUI [1,2])
Alcohol
Code List
Alcohol
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
integer
C0002667 (UMLS CUI [1])
Amphetamines
Code List
Amphetamines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Barbiturates
integer
C0004745 (UMLS CUI [1])
Barbiturates
Code List
Barbiturates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
integer
C0005064 (UMLS CUI [1])
Benzodiazepines
Code List
Benzodiazepines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cocaine Metabolite
integer
C0009170 (UMLS CUI [1])
Cocaine Metabolite
Code List
Cocaine Metabolite
CL Item
Positive (1)
CL Item
Negative (2)
Item
Ethanol
integer
C0001962 (UMLS CUI [1])
Ethanol
Code List
Ethanol
CL Item
Positive (1)
CL Item
Negative (2)
Item
Marijuana
integer
C0024808 (UMLS CUI [1])
Marijuana
Code List
Marijuana
CL Item
Positive (1)
CL Item
Negative (2)
Item
Methadone
integer
C0025605 (UMLS CUI [1])
Methadone
Code List
Methadone
CL Item
Positive (1)
CL Item
Negative (2)
Item
Methaqualone
integer
C0025627 (UMLS CUI [1])
Methaqualone
Code List
Methaqualone
CL Item
Positive (1)
CL Item
Negative (2)
Item
Opiates
integer
C0376196 (UMLS CUI [1])
Opiates
Code List
Opiates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Phencyclidine
integer
C0031381 (UMLS CUI [1])
Phencyclidine
Code List
Phencyclidine
CL Item
Positive (1)
CL Item
Negative (2)
Item
Propoxyphene
integer
C0202458 (UMLS CUI [1])
Propoxyphene
Code List
Propoxyphene
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cotinine
integer
C0202363 (UMLS CUI [1])
Cotinine
Code List
Cotinine
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Serology / HIV Screen
C0459958 (UMLS CUI-1)
C0036743 (UMLS CUI-3)
Date Sample Taken
Item
Date Sample Taken
date
C1302413 (UMLS CUI [1])
Item
Hepatitis B Surface Antigen
integer
C0149709 (UMLS CUI [1])
Hepatitis B Surface Antigen
Code List
Hepatitis B Surface Antigen
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis C Antibody
integer
C0281863 (UMLS CUI [1])
Hepatitis C Antibody
Code List
Hepatitis C Antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item
HIV Antibody
integer
C3714540 (UMLS CUI [1])
HIV Antibody
Code List
HIV Antibody
CL Item
Positive (1)
CL Item
Negative (2)
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