ID

42865

Descrição

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

Link

https://clinicaltrials.gov/show/NCT02375139

Palavras-chave

Versões (2)
  1. 18/07/2019 18/07/2019 -
  2. 17/09/2021 17/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

17 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02375139

Inglês

Eligibility Type 2 Diabetes Mellitus NCT02375139

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

Age | Gender Healthy

Tipo de dados

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
Descrição

Body Weight | Body mass index

Tipo de dados

boolean

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

Plasma fasting glucose measurement

Tipo de dados

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.
Descrição

Comprehension Clinical Trial | Informed Consent

Tipo de dados

boolean

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

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)
Descrição

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 de dados

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)
Descrição

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

Tipo de dados

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
Descrição

Aspirin allergy | Allergic reaction to antibiotics

Tipo de dados

boolean

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

Study Subject Participation Status

Tipo de dados

boolean

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

Blood Donation Whole | Blood Donation Component | Blood Transfusion

Tipo de dados

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
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02375139

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])
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