0 Ratings
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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