ID

15745

Description

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Healthy Japanese Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT01620463

Link

https://clinicaltrials.gov/show/NCT01620463

Keywords

Versions (1)
  1. 6/10/16 6/10/16 -
Uploaded on

June 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes NCT01620463

English

Eligibility Diabetes NCT01620463

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01620463
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
body mass index (bmi) between 18 and 27 kg/m^2, inclusive
Description

BMI

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically relevant abnormalities of physical examination, laboratory values, vital signs or ecg findings at the screening, as judged by the investigator or sub-investigator
Description

clinically relevant abnormalities

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0205161
UMLS CUI [2,1]
C1254595
UMLS CUI [2,2]
C0205161
UMLS CUI [3,1]
C0518766
UMLS CUI [3,2]
C0205161
UMLS CUI [4,1]
C0438154
UMLS CUI [4,2]
C0205161
presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous, as judged by the investigator
Description

presence of acute or chronic illness

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90-150 mmhg systolic or 40-90 mmhg diastolic
Description

blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
heart rate in supine position at the screening, after resting for 5 min, outside the range 40-100 beats/min
Description

heart rate

Data type

boolean

Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
alcohol intake within 48 hours prior to the screening
Description

alcohol intake

Data type

boolean

Alias
UMLS CUI [1]
C0001948
hepatitis b surface antigen, hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies positive
Description

antibodies

Data type

boolean

Alias
UMLS CUI [1]
C0019168
UMLS CUI [2]
C0166049
UMLS CUI [3]
C0019683
clinically relevant abnormal history or physical findings at the screening, which could interfere with the objectives of the study or the safety of the subject's participation, as judged by the investigator
Description

abnormal history or physical findings

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
history of significant allergy or hypersensitivity
Description

allergy

Data type

boolean

Alias
UMLS CUI [1]
C0020517
known or suspected allergy to trial product or related products
Description

allergy to trial product

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3854006
history of drug or alcohol abuse
Description

drug or alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
smoking 10 cigarettes or more, or the equivalent, per day and is unwilling to refrain from smoking during 3 days prior to dosing and during the confinement period
Description

smoking

Data type

boolean

Alias
UMLS CUI [1]
C0543414
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Similar models

Eligibility Diabetes NCT01620463

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01620463
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
BMI
Item
body mass index (bmi) between 18 and 27 kg/m^2, inclusive
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
clinically relevant abnormalities
Item
clinically relevant abnormalities of physical examination, laboratory values, vital signs or ecg findings at the screening, as judged by the investigator or sub-investigator
boolean
C0031809 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C1254595 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0518766 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
C0438154 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
presence of acute or chronic illness
Item
presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous, as judged by the investigator
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
blood pressure
Item
blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90-150 mmhg systolic or 40-90 mmhg diastolic
boolean
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
heart rate
Item
heart rate in supine position at the screening, after resting for 5 min, outside the range 40-100 beats/min
boolean
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
alcohol intake
Item
alcohol intake within 48 hours prior to the screening
boolean
C0001948 (UMLS CUI [1])
antibodies
Item
hepatitis b surface antigen, hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies positive
boolean
C0019168 (UMLS CUI [1])
C0166049 (UMLS CUI [2])
C0019683 (UMLS CUI [3])
abnormal history or physical findings
Item
clinically relevant abnormal history or physical findings at the screening, which could interfere with the objectives of the study or the safety of the subject's participation, as judged by the investigator
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
allergy
Item
history of significant allergy or hypersensitivity
boolean
C0020517 (UMLS CUI [1])
allergy to trial product
Item
known or suspected allergy to trial product or related products
boolean
C0020517 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
drug or alcohol abuse
Item
history of drug or alcohol abuse
boolean
C0038586 (UMLS CUI [1])
smoking
Item
smoking 10 cigarettes or more, or the equivalent, per day and is unwilling to refrain from smoking during 3 days prior to dosing and during the confinement period
boolean
C0543414 (UMLS CUI [1])
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