ID

32126

Beschrijving

A Study of the Bioequivalence of 12 mg Paliperidone Extended Release Tablets Manufactured at Gurabo and Vacaville; ODM derived from: https://clinicaltrials.gov/show/NCT00790777

Link

https://clinicaltrials.gov/show/NCT00790777

Trefwoorden

Versies (1)
  1. 19-10-18 19-10-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 oktober 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00790777

Engels

Eligibility Schizophrenia NCT00790777

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
Beschrijving

Barrier Contraception Double | Sperm donation Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004764
UMLS CUI [1,2]
C0205173
UMLS CUI [2,1]
C0871414
UMLS CUI [2,2]
C0332197
body mass index (weight [kg]/height [m2]) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
Beschrijving

Body mass index | Body Weight

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
blood pressure (after the patient is supine for 5 minutes) between 100 and 140 mmhg systolic, inclusive, and between 50 and 90 mmhg diastolic
Beschrijving

Lying systolic blood pressure | Lying diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C1319895
UMLS CUI [2]
C1319896
non-smoker
Beschrijving

Non-smoker

Datatype

boolean

Alias
UMLS CUI [1]
C0337672
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the volunteer
Beschrijving

Illness Significant | Cardiac Arrhythmia | Heart Diseases | Hematological Disease | Blood Coagulation Disorders | Bleeding tendency | Lipids abnormal | Lung diseases | Bronchial Spasm Associated with Respiration Disorders | Diabetes Mellitus | Renal Insufficiency | Hepatic Insufficiency | Thyroid Diseases | Nervous system disorder | Mental disorders | Communicable Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0018799
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0005779
UMLS CUI [6]
C1458140
UMLS CUI [7]
C0549634
UMLS CUI [8]
C0024115
UMLS CUI [9,1]
C0006266
UMLS CUI [9,2]
C0332281
UMLS CUI [9,3]
C0035204
UMLS CUI [10]
C0011849
UMLS CUI [11]
C1565489
UMLS CUI [12]
C1306571
UMLS CUI [13]
C0040128
UMLS CUI [14]
C0027765
UMLS CUI [15]
C0004936
UMLS CUI [16]
C0009450
history of any cancer, with the exception of basal cell carcinoma
Beschrijving

Malignant Neoplasms | Exception Basal cell carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center
Beschrijving

Hematology finding abnormal | Clinical Chemistry Finding Abnormal | Urinalysis abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0475182
UMLS CUI [2,1]
C2347783
UMLS CUI [2,2]
C0205161
UMLS CUI [3]
C0438142
clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ecg) at screening or at admission to the study center
Beschrijving

Physical Examination Abnormal Finding | Abnormal vital signs | 12 lead ECG Abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C2826636
UMLS CUI [2]
C0277804
UMLS CUI [3,1]
C0430456
UMLS CUI [3,2]
C0205161
at screening, has signs of autonomic dysfunction as indicated by a decrease of > 20 mmhg in systolic blood pressure or a decrease of > 10 mmhg in diastolic blood pressure after standing for at least 2 minutes that is not associated with an increase of >15 beats per minute (bpm) in heart rate
Beschrijving

Signs Autonomic dysfunction | Standing systolic blood pressure Decrease | Standing diastolic blood pressure Decrease | Independent of Heart rate increased

Datatype

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C1145628
UMLS CUI [2,1]
C1303018
UMLS CUI [2,2]
C0547047
UMLS CUI [3,1]
C1303019
UMLS CUI [3,2]
C0547047
UMLS CUI [4,1]
C0332291
UMLS CUI [4,2]
C0039231
bradycardia (heart rate <40 bpm) as determined by screening 12-lead ecg
Beschrijving

Bradycardia 12 lead ECG | Heart rate 12 lead ECG

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428977
UMLS CUI [1,2]
C0430456
UMLS CUI [2,1]
C0018810
UMLS CUI [2,2]
C0430456
use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol (acetaminophen) or ibuprofen, within 14 days before the first dose of the study drug is scheduled
Beschrijving

Prescription Drugs | Drugs, Non-Prescription | Vitamins | Herbal Supplements | Exception Acetaminophen | Exception Ibuprofen

Datatype

boolean

Alias
UMLS CUI [1]
C0304227
UMLS CUI [2]
C0013231
UMLS CUI [3]
C0042890
UMLS CUI [4]
C1504473
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0000970
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0020740
history of, or a reason to believe a volunteer has a history of, drug or alcohol abuse and/or dependence within the past 5 years
Beschrijving

Substance Use Disorders | Substance Dependence

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
known history of drug-induced dystonia or neuroleptic malignant syndrome
Beschrijving

Drug-induced dystonia | Neuroleptic Malignant Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0393595
UMLS CUI [2]
C0027849
positive test for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), or hepatitis c antibodies
Beschrijving

HIV antibody positive | Hepatitis B surface antigen positive | Hepatitis C antibody test positive

Datatype

boolean

Alias
UMLS CUI [1]
C0920548
UMLS CUI [2]
C0149709
UMLS CUI [3]
C1277805
history of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or volunteer's verbal report
Beschrijving

Tobacco use | Substance Containing Nicotine

Datatype

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2,1]
C0439861
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0028040
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Similar models

Eligibility Schizophrenia NCT00790777

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Barrier Contraception Double | Sperm donation Absent
Item
must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
boolean
C0004764 (UMLS CUI [1,1])
C0205173 (UMLS CUI [1,2])
C0871414 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Body mass index | Body Weight
Item
body mass index (weight [kg]/height [m2]) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Lying systolic blood pressure | Lying diastolic blood pressure
Item
blood pressure (after the patient is supine for 5 minutes) between 100 and 140 mmhg systolic, inclusive, and between 50 and 90 mmhg diastolic
boolean
C1319895 (UMLS CUI [1])
C1319896 (UMLS CUI [2])
Non-smoker
Item
non-smoker
boolean
C0337672 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Illness Significant | Cardiac Arrhythmia | Heart Diseases | Hematological Disease | Blood Coagulation Disorders | Bleeding tendency | Lipids abnormal | Lung diseases | Bronchial Spasm Associated with Respiration Disorders | Diabetes Mellitus | Renal Insufficiency | Hepatic Insufficiency | Thyroid Diseases | Nervous system disorder | Mental disorders | Communicable Disease
Item
history of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the volunteer
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0003811 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0005779 (UMLS CUI [5])
C1458140 (UMLS CUI [6])
C0549634 (UMLS CUI [7])
C0024115 (UMLS CUI [8])
C0006266 (UMLS CUI [9,1])
C0332281 (UMLS CUI [9,2])
C0035204 (UMLS CUI [9,3])
C0011849 (UMLS CUI [10])
C1565489 (UMLS CUI [11])
C1306571 (UMLS CUI [12])
C0040128 (UMLS CUI [13])
C0027765 (UMLS CUI [14])
C0004936 (UMLS CUI [15])
C0009450 (UMLS CUI [16])
Malignant Neoplasms | Exception Basal cell carcinoma
Item
history of any cancer, with the exception of basal cell carcinoma
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
Hematology finding abnormal | Clinical Chemistry Finding Abnormal | Urinalysis abnormal
Item
clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center
boolean
C0475182 (UMLS CUI [1])
C2347783 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0438142 (UMLS CUI [3])
Physical Examination Abnormal Finding | Abnormal vital signs | 12 lead ECG Abnormal
Item
clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ecg) at screening or at admission to the study center
boolean
C2826636 (UMLS CUI [1])
C0277804 (UMLS CUI [2])
C0430456 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
Signs Autonomic dysfunction | Standing systolic blood pressure Decrease | Standing diastolic blood pressure Decrease | Independent of Heart rate increased
Item
at screening, has signs of autonomic dysfunction as indicated by a decrease of > 20 mmhg in systolic blood pressure or a decrease of > 10 mmhg in diastolic blood pressure after standing for at least 2 minutes that is not associated with an increase of >15 beats per minute (bpm) in heart rate
boolean
C0311392 (UMLS CUI [1,1])
C1145628 (UMLS CUI [1,2])
C1303018 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
C1303019 (UMLS CUI [3,1])
C0547047 (UMLS CUI [3,2])
C0332291 (UMLS CUI [4,1])
C0039231 (UMLS CUI [4,2])
Bradycardia 12 lead ECG | Heart rate 12 lead ECG
Item
bradycardia (heart rate <40 bpm) as determined by screening 12-lead ecg
boolean
C0428977 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0018810 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
Prescription Drugs | Drugs, Non-Prescription | Vitamins | Herbal Supplements | Exception Acetaminophen | Exception Ibuprofen
Item
use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol (acetaminophen) or ibuprofen, within 14 days before the first dose of the study drug is scheduled
boolean
C0304227 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C0042890 (UMLS CUI [3])
C1504473 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0000970 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0020740 (UMLS CUI [6,2])
Substance Use Disorders | Substance Dependence
Item
history of, or a reason to believe a volunteer has a history of, drug or alcohol abuse and/or dependence within the past 5 years
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Drug-induced dystonia | Neuroleptic Malignant Syndrome
Item
known history of drug-induced dystonia or neuroleptic malignant syndrome
boolean
C0393595 (UMLS CUI [1])
C0027849 (UMLS CUI [2])
HIV antibody positive | Hepatitis B surface antigen positive | Hepatitis C antibody test positive
Item
positive test for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), or hepatitis c antibodies
boolean
C0920548 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1277805 (UMLS CUI [3])
Tobacco use | Substance Containing Nicotine
Item
history of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or volunteer's verbal report
boolean
C0543414 (UMLS CUI [1])
C0439861 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0028040 (UMLS CUI [2,3])
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