ID

39199

Description

A Study to Evaluate the Effect of Ketoconazole and Rifampicin on the Pharmacokinetics of Fimasartan in Healthy Male Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT00938262

Link

https://clinicaltrials.gov/show/NCT00938262

Keywords

Versions (1)
  1. 12/9/19 12/9/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 9, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Essential Hypertension NCT00938262

English

Eligibility Essential Hypertension NCT00938262

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age: 20 - 45 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
sex: male
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
body weight: greater than 55 kg
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known allergy to fimasartan, ketoconazole and rifampicin
Description

Hypersensitivity Fimasartan | Ketoconazole allergy | Rifampicin allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2825622
UMLS CUI [2]
C0571275
UMLS CUI [3]
C0571521
existing cardiac or hematological diseases
Description

Heart Disease | Hematological Disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0018939
existing hepatic and renal diseases
Description

Liver diseases | Kidney Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
existing gastrointestinal diseases
Description

Gastrointestinal Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0017178
acute or chronic diseases which could affect drug absorption or metabolism
Description

Disease Affecting Drug absorption | Disease Affecting Drug metabolism | Chronic disease Affecting Drug absorption | Chronic disease Affecting Drug metabolism

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0683140
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0678745
UMLS CUI [4,1]
C0008679
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0683140
history of any serious psychological disorder
Description

Serious mental illness

Data type

boolean

Alias
UMLS CUI [1]
C3841614
positive drug or alcohol screening
Description

Drug screen positive | Alcohol consumption screening Positive

Data type

boolean

Alias
UMLS CUI [1]
C0743295
UMLS CUI [2,1]
C0420032
UMLS CUI [2,2]
C1514241
smokers of 10 or more cigarettes per day 3 month ago
Description

Tobacco use Number of cigarettes per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
participation in a clinical trial during the last 2 months prior to the start of the study
Description

Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
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Similar models

Eligibility Essential Hypertension NCT00938262

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age: 20 - 45 years
boolean
C0001779 (UMLS CUI [1])
Gender
Item
sex: male
boolean
C0079399 (UMLS CUI [1])
Body Weight
Item
body weight: greater than 55 kg
boolean
C0005910 (UMLS CUI [1])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Fimasartan | Ketoconazole allergy | Rifampicin allergy
Item
known allergy to fimasartan, ketoconazole and rifampicin
boolean
C0020517 (UMLS CUI [1,1])
C2825622 (UMLS CUI [1,2])
C0571275 (UMLS CUI [2])
C0571521 (UMLS CUI [3])
Heart Disease | Hematological Disease
Item
existing cardiac or hematological diseases
boolean
C0018799 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
Liver diseases | Kidney Diseases
Item
existing hepatic and renal diseases
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
Gastrointestinal Diseases
Item
existing gastrointestinal diseases
boolean
C0017178 (UMLS CUI [1])
Disease Affecting Drug absorption | Disease Affecting Drug metabolism | Chronic disease Affecting Drug absorption | Chronic disease Affecting Drug metabolism
Item
acute or chronic diseases which could affect drug absorption or metabolism
boolean
C0012634 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0683140 (UMLS CUI [2,3])
C0008679 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0678745 (UMLS CUI [3,3])
C0008679 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0683140 (UMLS CUI [4,3])
Serious mental illness
Item
history of any serious psychological disorder
boolean
C3841614 (UMLS CUI [1])
Drug screen positive | Alcohol consumption screening Positive
Item
positive drug or alcohol screening
boolean
C0743295 (UMLS CUI [1])
C0420032 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Tobacco use Number of cigarettes per day
Item
smokers of 10 or more cigarettes per day 3 month ago
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Study Subject Participation Status | Clinical Trial
Item
participation in a clinical trial during the last 2 months prior to the start of the study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
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