ID

23931

Descripción

Healthy Volunteer Study of Clopidogrel and Rifampicin; ODM derived from: https://clinicaltrials.gov/show/NCT00696566

Link

https://clinicaltrials.gov/show/NCT00696566

Palabras clave

Versiones (1)
  1. 18/7/17 18/7/17 -
Subido en

18 de julio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00696566

Inglés

Eligibility Coronary Artery Disease NCT00696566

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male subjects, or female subjects not of childbearing potential (either surgically sterile or post menopausal).
Descripción

Gender Healthy | Gender Childbearing Potential Lacking | Female Sterilization | Postmenopausal state

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3898900
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C3831118
UMLS CUI [2,3]
C0332268
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0232970
age between 18 and 65 years inclusive.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
non smokers.
Descripción

Non-smoker

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0337672
body mass index (bmi) between 18 and 28 kg/m2 inclusive, with a body weight between 60 - 100 kg.
Descripción

Body mass index | Body Weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
subjects are to be in good health as determined by a medical history, physical examination including vital signs, and clinical laboratory test results including liver function and full blood count.
Descripción

Overall Well Being | Medical History | Physical Examination | Vital signs | Laboratory test finding | Liver function | Complete Blood Count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3813622
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0518766
UMLS CUI [5]
C0587081
UMLS CUI [6]
C0232741
UMLS CUI [7]
C0009555
subjects have given their signed informed consent before any trial−related activity.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
in the opinion of the investigator, subjects with, or a history of, cancer, diabetes or clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, haematological, dermatological, neurological, psychiatric or other major disorders.
Descripción

Malignant Neoplasms | Diabetes Mellitus | Cardiovascular Diseases | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Hematological Disease | Dermatologic disorders | nervous system disorder | Mental disorders | Disease Major

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0035204
UMLS CUI [5]
C0025517
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0023895
UMLS CUI [8]
C0017178
UMLS CUI [9]
C0018939
UMLS CUI [10]
C0037274
UMLS CUI [11]
C0027765
UMLS CUI [12]
C0004936
UMLS CUI [13,1]
C0012634
UMLS CUI [13,2]
C0205164
subjects with a history of significant multiple drug allergies or with a known allergy to the study drugs or any medicine chemically related to the trial product.
Descripción

DRUG ALLERGY MULTIPLE | Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Investigational New Drugs Related

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0743280
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0013230
UMLS CUI [3,4]
C0439849
subjects who have a clinically significant allergic disease (including hay fever).
Descripción

Allergic disorder | Hay fever

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C0018621
subjects who have had a clinically significant illness within 4 weeks of dosing.
Descripción

Illness Clinical Significance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2826293
subjects taking regular medication including nsaid's, antibiotics, aspirin or anticoagulant therapy.
Descripción

Pharmaceutical Preparations Intake Regular | Anti-Inflammatory Agents, Non-Steroidal | Antibiotics | Aspirin | Anticoagulant therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C0205272
UMLS CUI [2]
C0003211
UMLS CUI [3]
C0003232
UMLS CUI [4]
C0004057
UMLS CUI [5]
C0150457
any clinically significant abnormal laboratory test results at screening.
Descripción

Laboratory test result abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438215
subjects who have a supine blood pressure at screening, after resting for 5 min higher than 150/90 mmhg or lower than 100/50 mmhg.
Descripción

Blood pressure Supine Post Rest

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1271104
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0035253
subjects who have a supine heart rate at screening, after resting for 5 minutes outside the range of 40 - 90 beats/min.
Descripción

Heart rate Supine Post Rest

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0687676
UMLS CUI [1,4]
C0035253
subjects who have received any prescribed systemic or topical medication within two weeks prior to screening (although occasional use of paracetamol is permitted at the discretion of the investigator).
Descripción

Pharmaceutical Preparations Systemic prescribed | Pharmaceutical Preparations Topical prescribed | Acetaminophen Infrequent allowed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0278329
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C1522168
UMLS CUI [2,3]
C0278329
UMLS CUI [3,1]
C0000970
UMLS CUI [3,2]
C0521114
UMLS CUI [3,3]
C0683607
subjects who have received an investigational medicinal product within the previous four months (new chemical entity) or three months (licensed product) or subjects who have received a vaccine within three months preceding the start of dosing.
Descripción

Investigational New Drugs | Vaccines

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0042210
subjects who have donated any blood or plasma in the past month or in excess of 500 ml within twelve weeks preceding screening.
Descripción

Blood Donation | Plasma Donation | Blood Donation Excessive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0032105
UMLS CUI [2,2]
C0680854
UMLS CUI [3,1]
C0005794
UMLS CUI [3,2]
C0442802
subjects who have a history of alcohol or drug abuse (consume greater than 28 units per week [one unit of alcohol equals 250 ml of beer or lager or one glass of wine or 20 ml of spirits]).
Descripción

Substance Use Disorders | Alcohol consumption U/week | Beer | Lager | Wine | Spirit

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0560588
UMLS CUI [3]
C0004922
UMLS CUI [4]
C0452245
UMLS CUI [5]
C0043188
UMLS CUI [6]
C0301611
subjects with mental incapacity or language barriers which preclude adequate understanding.
Descripción

Mental handicap Excludes Comprehension | Language Barriers Exclude Comprehension

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1306341
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0162340
UMLS CUI [2,1]
C0237167
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0162340
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Similar models

Eligibility Coronary Artery Disease NCT00696566

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender Healthy | Gender Childbearing Potential Lacking | Female Sterilization | Postmenopausal state
Item
healthy male subjects, or female subjects not of childbearing potential (either surgically sterile or post menopausal).
boolean
C0079399 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C3831118 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
C0015787 (UMLS CUI [3])
C0232970 (UMLS CUI [4])
Age
Item
age between 18 and 65 years inclusive.
boolean
C0001779 (UMLS CUI [1])
Non-smoker
Item
non smokers.
boolean
C0337672 (UMLS CUI [1])
Body mass index | Body Weight
Item
body mass index (bmi) between 18 and 28 kg/m2 inclusive, with a body weight between 60 - 100 kg.
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Overall Well Being | Medical History | Physical Examination | Vital signs | Laboratory test finding | Liver function | Complete Blood Count
Item
subjects are to be in good health as determined by a medical history, physical examination including vital signs, and clinical laboratory test results including liver function and full blood count.
boolean
C3813622 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0518766 (UMLS CUI [4])
C0587081 (UMLS CUI [5])
C0232741 (UMLS CUI [6])
C0009555 (UMLS CUI [7])
Informed Consent
Item
subjects have given their signed informed consent before any trial−related activity.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasms | Diabetes Mellitus | Cardiovascular Diseases | Respiration Disorders | Metabolic Diseases | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Hematological Disease | Dermatologic disorders | nervous system disorder | Mental disorders | Disease Major
Item
in the opinion of the investigator, subjects with, or a history of, cancer, diabetes or clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, haematological, dermatological, neurological, psychiatric or other major disorders.
boolean
C0006826 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0025517 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0023895 (UMLS CUI [7])
C0017178 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0037274 (UMLS CUI [10])
C0027765 (UMLS CUI [11])
C0004936 (UMLS CUI [12])
C0012634 (UMLS CUI [13,1])
C0205164 (UMLS CUI [13,2])
DRUG ALLERGY MULTIPLE | Hypersensitivity Investigational New Drugs | Hypersensitivity Pharmaceutical Preparations Investigational New Drugs Related
Item
subjects with a history of significant multiple drug allergies or with a known allergy to the study drugs or any medicine chemically related to the trial product.
boolean
C0743280 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0013230 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
Allergic disorder | Hay fever
Item
subjects who have a clinically significant allergic disease (including hay fever).
boolean
C0020517 (UMLS CUI [1])
C0018621 (UMLS CUI [2])
Illness Clinical Significance
Item
subjects who have had a clinically significant illness within 4 weeks of dosing.
boolean
C0221423 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
Pharmaceutical Preparations Intake Regular | Anti-Inflammatory Agents, Non-Steroidal | Antibiotics | Aspirin | Anticoagulant therapy
Item
subjects taking regular medication including nsaid's, antibiotics, aspirin or anticoagulant therapy.
boolean
C0013227 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2])
C0003232 (UMLS CUI [3])
C0004057 (UMLS CUI [4])
C0150457 (UMLS CUI [5])
Laboratory test result abnormal
Item
any clinically significant abnormal laboratory test results at screening.
boolean
C0438215 (UMLS CUI [1])
Blood pressure Supine Post Rest
Item
subjects who have a supine blood pressure at screening, after resting for 5 min higher than 150/90 mmhg or lower than 100/50 mmhg.
boolean
C1271104 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0035253 (UMLS CUI [1,4])
Heart rate Supine Post Rest
Item
subjects who have a supine heart rate at screening, after resting for 5 minutes outside the range of 40 - 90 beats/min.
boolean
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0687676 (UMLS CUI [1,3])
C0035253 (UMLS CUI [1,4])
Pharmaceutical Preparations Systemic prescribed | Pharmaceutical Preparations Topical prescribed | Acetaminophen Infrequent allowed
Item
subjects who have received any prescribed systemic or topical medication within two weeks prior to screening (although occasional use of paracetamol is permitted at the discretion of the investigator).
boolean
C0013227 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0278329 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1522168 (UMLS CUI [2,2])
C0278329 (UMLS CUI [2,3])
C0000970 (UMLS CUI [3,1])
C0521114 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
Investigational New Drugs | Vaccines
Item
subjects who have received an investigational medicinal product within the previous four months (new chemical entity) or three months (licensed product) or subjects who have received a vaccine within three months preceding the start of dosing.
boolean
C0013230 (UMLS CUI [1])
C0042210 (UMLS CUI [2])
Blood Donation | Plasma Donation | Blood Donation Excessive
Item
subjects who have donated any blood or plasma in the past month or in excess of 500 ml within twelve weeks preceding screening.
boolean
C0005794 (UMLS CUI [1])
C0032105 (UMLS CUI [2,1])
C0680854 (UMLS CUI [2,2])
C0005794 (UMLS CUI [3,1])
C0442802 (UMLS CUI [3,2])
Substance Use Disorders | Alcohol consumption U/week | Beer | Lager | Wine | Spirit
Item
subjects who have a history of alcohol or drug abuse (consume greater than 28 units per week [one unit of alcohol equals 250 ml of beer or lager or one glass of wine or 20 ml of spirits]).
boolean
C0038586 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0560588 (UMLS CUI [2,2])
C0004922 (UMLS CUI [3])
C0452245 (UMLS CUI [4])
C0043188 (UMLS CUI [5])
C0301611 (UMLS CUI [6])
Mental handicap Excludes Comprehension | Language Barriers Exclude Comprehension
Item
subjects with mental incapacity or language barriers which preclude adequate understanding.
boolean
C1306341 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C0237167 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
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