ID

32922

Descrição

A Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of Sustained Release(SR) Exenatide; ODM derived from: https://clinicaltrials.gov/show/NCT00964262

Link

https://clinicaltrials.gov/show/NCT00964262

Palavras-chave

Versões (1)
  1. 20/11/2018 20/11/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

20 de novembro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00964262

Inglês

Eligibility Type 2 Diabetes Mellitus NCT00964262

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male subjects aged 20-45 years at screening
Descrição

Healthy Volunteers | Gender | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
body weight over 50 kg, inclusive, and within 20% of ideal body weight
Descrição

Body Weight | Ideal Body Weight Percentage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2,1]
C0421272
UMLS CUI [2,2]
C0439165
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
has a present illness or medical history of hepatic, renal, respiratory, cardiovascular disease, blood tumor, mental disorder, and endocrinologic disorder, especially diabetes mellitus
Descrição

Liver disease | Kidney Disease | Respiration Disorder | Cardiovascular Disease | Hematologic Neoplasm | Mental disorder | Endocrine System Disease | Diabetes Mellitus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0035204
UMLS CUI [4]
C0007222
UMLS CUI [5]
C0376545
UMLS CUI [6]
C0004936
UMLS CUI [7]
C0014130
UMLS CUI [8]
C0011849
has a sign or symptom or history related to an acute or chronic pancreatitis
Descrição

Sign or Symptom Pancreatitis | Sign or Symptom Chronic Pancreatitis | History of pancreatitis | Medical History Chronic Pancreatitis

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0030305
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0149521
UMLS CUI [3]
C3887021
UMLS CUI [4,1]
C0262926
UMLS CUI [4,2]
C0149521
has a known allergy or hypersensitivity to exenatide or other drugs such as aspirin, antibiotics, and so on
Descrição

Hypersensitivity Exenatide | Aspirin allergy | Allergy to antibiotic agents

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0167117
UMLS CUI [2]
C0004058
UMLS CUI [3]
C0455591
has ever been exposed to exenatide
Descrição

Exposure to Exenatide

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0167117
shows sbp >= 150 mmhg or <= 90 mmhg or dbp >= 100 mmhg or <= 50 mmhg
Descrição

Systolic Pressure | Diastolic blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
has a presence or history of drug abuse
Descrição

Drug abuse

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013146
uses any prescription drug, herbal medicine within 2 weeks or otc drugs or vitamin within 1 week prior to study drug administration
Descrição

Prescription of drug | Medicinal Herbs | Drugs, Non-Prescription | Vitamins

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2239117
UMLS CUI [2]
C0025125
UMLS CUI [3]
C0013231
UMLS CUI [4]
C0042890
has been participated in other clinical trial within 2 months
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
has experience of a blood donation during 2 months or a blood transfusion during 1 month prior to study drug administration
Descrição

Blood Donation | Blood Transfusion

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2]
C0005841
heavy smoker more than 10 cigarettes/day within 3 months prior to screening
Descrição

Heavy smoker Number of cigarettes per day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0857118
UMLS CUI [1,2]
C3694146
continuous drinker (over 21 units/week, 1 unit = 10 g of pure alcohol) or subject who can't quit drinking nor smoking during clinical trial period
Descrição

Alcohol consumption Continuous U/week | unable to stop drinking | unable to stop smoking

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C0560588
UMLS CUI [2]
C0849744
UMLS CUI [3]
C0849745
subjects not eligible at the discretion of investigators
Descrição

Study Subject Participation Status Ineligible

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00964262

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Gender | Age
Item
healthy male subjects aged 20-45 years at screening
boolean
C1708335 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Body Weight | Ideal Body Weight Percentage
Item
body weight over 50 kg, inclusive, and within 20% of ideal body weight
boolean
C0005910 (UMLS CUI [1])
C0421272 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Liver disease | Kidney Disease | Respiration Disorder | Cardiovascular Disease | Hematologic Neoplasm | Mental disorder | Endocrine System Disease | Diabetes Mellitus
Item
has a present illness or medical history of hepatic, renal, respiratory, cardiovascular disease, blood tumor, mental disorder, and endocrinologic disorder, especially diabetes mellitus
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0035204 (UMLS CUI [3])
C0007222 (UMLS CUI [4])
C0376545 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
C0014130 (UMLS CUI [7])
C0011849 (UMLS CUI [8])
Sign or Symptom Pancreatitis | Sign or Symptom Chronic Pancreatitis | History of pancreatitis | Medical History Chronic Pancreatitis
Item
has a sign or symptom or history related to an acute or chronic pancreatitis
boolean
C3540840 (UMLS CUI [1,1])
C0030305 (UMLS CUI [1,2])
C3540840 (UMLS CUI [2,1])
C0149521 (UMLS CUI [2,2])
C3887021 (UMLS CUI [3])
C0262926 (UMLS CUI [4,1])
C0149521 (UMLS CUI [4,2])
Hypersensitivity Exenatide | Aspirin allergy | Allergy to antibiotic agents
Item
has a known allergy or hypersensitivity to exenatide or other drugs such as aspirin, antibiotics, and so on
boolean
C0020517 (UMLS CUI [1,1])
C0167117 (UMLS CUI [1,2])
C0004058 (UMLS CUI [2])
C0455591 (UMLS CUI [3])
Exposure to Exenatide
Item
has ever been exposed to exenatide
boolean
C0332157 (UMLS CUI [1,1])
C0167117 (UMLS CUI [1,2])
Systolic Pressure | Diastolic blood pressure
Item
shows sbp >= 150 mmhg or <= 90 mmhg or dbp >= 100 mmhg or <= 50 mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Drug abuse
Item
has a presence or history of drug abuse
boolean
C0013146 (UMLS CUI [1])
Prescription of drug | Medicinal Herbs | Drugs, Non-Prescription | Vitamins
Item
uses any prescription drug, herbal medicine within 2 weeks or otc drugs or vitamin within 1 week prior to study drug administration
boolean
C2239117 (UMLS CUI [1])
C0025125 (UMLS CUI [2])
C0013231 (UMLS CUI [3])
C0042890 (UMLS CUI [4])
Study Subject Participation Status
Item
has been participated in other clinical trial within 2 months
boolean
C2348568 (UMLS CUI [1])
Blood Donation | Blood Transfusion
Item
has experience of a blood donation during 2 months or a blood transfusion during 1 month prior to study drug administration
boolean
C0005794 (UMLS CUI [1])
C0005841 (UMLS CUI [2])
Heavy smoker Number of cigarettes per day
Item
heavy smoker more than 10 cigarettes/day within 3 months prior to screening
boolean
C0857118 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Alcohol consumption Continuous U/week | unable to stop drinking | unable to stop smoking
Item
continuous drinker (over 21 units/week, 1 unit = 10 g of pure alcohol) or subject who can't quit drinking nor smoking during clinical trial period
boolean
C0001948 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0560588 (UMLS CUI [1,3])
C0849744 (UMLS CUI [2])
C0849745 (UMLS CUI [3])
Study Subject Participation Status Ineligible
Item
subjects not eligible at the discretion of investigators
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
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