ID

24156

Description

GSK372475 Bioequivalence Study; ODM derived from: https://clinicaltrials.gov/show/NCT00488098

Link

https://clinicaltrials.gov/show/NCT00488098

Keywords

  1. 7/26/17 7/26/17 -
Uploaded on

July 26, 2017

DOI

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License

Creative Commons BY-NC 3.0

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Eligibility Healthy Subjects NCT00488098

Eligibility Healthy Subjects NCT00488098

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy males/females aged 18-45 years
Description

Healthy Volunteers | Age

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0001779
non-smokers
Description

Non-smoker

Data type

boolean

Alias
UMLS CUI [1]
C0337672
bmi 19-30 kg.m2
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
qtc<450msec
Description

QTc

Data type

boolean

Alias
UMLS CUI [1]
C0860814
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
use of oral contraception
Description

Oral contraception

Data type

boolean

Alias
UMLS CUI [1]
C0029151
positive breath alcohol and drug screen
Description

Breath alcohol test positive | Drug screen positive

Data type

boolean

Alias
UMLS CUI [1]
C1112499
UMLS CUI [2]
C0743295
regular alcohol consumption
Description

Alcohol consumption Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205272
current psychiatric illness or within 1 year.
Description

Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0004936
history of gi, hepatic or renal disease
Description

Gastrointestinal Disease | Liver disease | Kidney Disease

Data type

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885

Similar models

Eligibility Healthy Subjects NCT00488098

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Age
Item
healthy males/females aged 18-45 years
boolean
C1708335 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Non-smoker
Item
non-smokers
boolean
C0337672 (UMLS CUI [1])
Body mass index
Item
bmi 19-30 kg.m2
boolean
C1305855 (UMLS CUI [1])
QTc
Item
qtc<450msec
boolean
C0860814 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Oral contraception
Item
use of oral contraception
boolean
C0029151 (UMLS CUI [1])
Breath alcohol test positive | Drug screen positive
Item
positive breath alcohol and drug screen
boolean
C1112499 (UMLS CUI [1])
C0743295 (UMLS CUI [2])
Alcohol consumption Regular
Item
regular alcohol consumption
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Mental disorders
Item
current psychiatric illness or within 1 year.
boolean
C0004936 (UMLS CUI [1])
Gastrointestinal Disease | Liver disease | Kidney Disease
Item
history of gi, hepatic or renal disease
boolean
C0017178 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])

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