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ID

42865

Descrizione

A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg in Healthy Male Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT02375139

collegamento

https://clinicaltrials.gov/show/NCT02375139

Keywords

versioni (2)
  1. 18/07/19 18/07/19 -
  2. 17/09/21 17/09/21 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

17 settembre 2021

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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    Eligibility Type 2 Diabetes Mellitus NCT02375139

    Inglese

    Eligibility Type 2 Diabetes Mellitus NCT02375139

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    age between 19 to 45, healthy male subjects(at screening)
    Descrizione

    Age | Gender Healthy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2,1]
    C0079399
    UMLS CUI [2,2]
    C3898900
    body weight between 55kg - 90kg, bmi between 18.0 - 27.0
    Descrizione

    Body Weight | Body mass index

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0005910
    UMLS CUI [2]
    C1305855
    fpg 60-125mg/dl glucose level(at screening)
    Descrizione

    Plasma fasting glucose measurement

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0583513
    volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
    Descrizione

    Comprehension Clinical Trial | Informed Consent

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0162340
    UMLS CUI [1,2]
    C0008976
    UMLS CUI [2]
    C0021430
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
    Descrizione

    Liver disease | Carrier of viral hepatitis | Kidney Disease | Nervous system disorder | Immune System Disease | Lung disease | Endocrine System Disease | Hematologic Neoplasm | Heart Disease | Mental disorder

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0023895
    UMLS CUI [2]
    C0733680
    UMLS CUI [3]
    C0022658
    UMLS CUI [4]
    C0027765
    UMLS CUI [5]
    C0021053
    UMLS CUI [6]
    C0024115
    UMLS CUI [7]
    C0014130
    UMLS CUI [8]
    C0376545
    UMLS CUI [9]
    C0018799
    UMLS CUI [10]
    C0004936
    volunteer who had gi tract disease(crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
    Descrizione

    Gastrointestinal Disease | Crohn Disease | Ulcer | Pancreatitis | Pancreatitis, Chronic | Gastrointestinal Surgical Procedure | Exception Appendectomy | Exception Hernioplasty

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0017178
    UMLS CUI [2]
    C0010346
    UMLS CUI [3]
    C0041582
    UMLS CUI [4]
    C0030305
    UMLS CUI [5]
    C0149521
    UMLS CUI [6]
    C0524722
    UMLS CUI [7,1]
    C1705847
    UMLS CUI [7,2]
    C0003611
    UMLS CUI [8,1]
    C1705847
    UMLS CUI [8,2]
    C0019328
    volunteer who had drug(aspirin, antibiotics) hypersensitivity reaction
    Descrizione

    Aspirin allergy | Allergic reaction to antibiotics

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0004058
    UMLS CUI [2]
    C0850093
    subject who already participated in other trials in 2 months
    Descrizione

    Study Subject Participation Status

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
    Descrizione

    Blood Donation Whole | Blood Donation Component | Blood Transfusion

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0005794
    UMLS CUI [1,2]
    C0439751
    UMLS CUI [2,1]
    C0005794
    UMLS CUI [2,2]
    C1705248
    UMLS CUI [3]
    C0005841
    Ritorna all'inizio della pagina

    Similar models

    Eligibility Type 2 Diabetes Mellitus NCT02375139

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age | Gender Healthy
    Item
    age between 19 to 45, healthy male subjects(at screening)
    boolean
    C0001779 (UMLS CUI [1])
    C0079399 (UMLS CUI [2,1])
    C3898900 (UMLS CUI [2,2])
    Body Weight | Body mass index
    Item
    body weight between 55kg - 90kg, bmi between 18.0 - 27.0
    boolean
    C0005910 (UMLS CUI [1])
    C1305855 (UMLS CUI [2])
    Plasma fasting glucose measurement
    Item
    fpg 60-125mg/dl glucose level(at screening)
    boolean
    C0583513 (UMLS CUI [1])
    Comprehension Clinical Trial | Informed Consent
    Item
    volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
    boolean
    C0162340 (UMLS CUI [1,1])
    C0008976 (UMLS CUI [1,2])
    C0021430 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Liver disease | Carrier of viral hepatitis | Kidney Disease | Nervous system disorder | Immune System Disease | Lung disease | Endocrine System Disease | Hematologic Neoplasm | Heart Disease | Mental disorder
    Item
    volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
    boolean
    C0023895 (UMLS CUI [1])
    C0733680 (UMLS CUI [2])
    C0022658 (UMLS CUI [3])
    C0027765 (UMLS CUI [4])
    C0021053 (UMLS CUI [5])
    C0024115 (UMLS CUI [6])
    C0014130 (UMLS CUI [7])
    C0376545 (UMLS CUI [8])
    C0018799 (UMLS CUI [9])
    C0004936 (UMLS CUI [10])
    Gastrointestinal Disease | Crohn Disease | Ulcer | Pancreatitis | Pancreatitis, Chronic | Gastrointestinal Surgical Procedure | Exception Appendectomy | Exception Hernioplasty
    Item
    volunteer who had gi tract disease(crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
    boolean
    C0017178 (UMLS CUI [1])
    C0010346 (UMLS CUI [2])
    C0041582 (UMLS CUI [3])
    C0030305 (UMLS CUI [4])
    C0149521 (UMLS CUI [5])
    C0524722 (UMLS CUI [6])
    C1705847 (UMLS CUI [7,1])
    C0003611 (UMLS CUI [7,2])
    C1705847 (UMLS CUI [8,1])
    C0019328 (UMLS CUI [8,2])
    Aspirin allergy | Allergic reaction to antibiotics
    Item
    volunteer who had drug(aspirin, antibiotics) hypersensitivity reaction
    boolean
    C0004058 (UMLS CUI [1])
    C0850093 (UMLS CUI [2])
    Study Subject Participation Status
    Item
    subject who already participated in other trials in 2 months
    boolean
    C2348568 (UMLS CUI [1])
    Blood Donation Whole | Blood Donation Component | Blood Transfusion
    Item
    subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
    boolean
    C0005794 (UMLS CUI [1,1])
    C0439751 (UMLS CUI [1,2])
    C0005794 (UMLS CUI [2,1])
    C1705248 (UMLS CUI [2,2])
    C0005841 (UMLS CUI [3])
    Ritorna all'inizio della pagina 

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