0 Avaliações
ID

44273

Descrição

A Pharmacokinetic Study of the Relative Bioavailability of Paliperidone ER Formulations With Different Release Profiles and a Comparison to Paliperidone IR; ODM derived from: https://clinicaltrials.gov/show/NCT00791193

Link

https://clinicaltrials.gov/show/NCT00791193

Palavras-chave

Versões (2)
  1. 20/10/2018 20/10/2018 -
  2. 20/09/2021 20/09/2021 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Schizophrenia NCT00791193

    Inglês

    Eligibility Schizophrenia NCT00791193

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    must agree to use an efficient method of birth control as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
    Descrição

    Contraceptive methods | Sperm donation Absent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    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
    Descrição

    Body mass index | Body Weight

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    UMLS CUI [2]
    C0005910
    blood pressure (after the volunteer is supine for 5 minutes) between 100 and 140 mmhg systolic, inclusive, and between 50 and 90 mmhg diastolic. pulse rate measured over 60 seconds should be between 40 and 100 beats per minute (bpm)
    Descrição

    Lying systolic blood pressure | Lying diastolic blood pressure | Pulse Rate

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1319895
    UMLS CUI [2]
    C1319896
    UMLS CUI [3]
    C0232117
    non-smoker
    Descrição

    Non-smoker

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0337672
    Exclusion Criteria
    Descrição

    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
    Descrição

    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

    Tipo de dados

    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 or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the qtc interval, including: bradycardia (heart rate < 40 bpm on the ecg), clinically significant abnormality on the ecg, demonstration of repeated prolonged qtcf > 450 ms (qtc interval corrected for heart rate using fridericia's formula), as measured on more than one ecg (either during screening, or from prior medical record)
    Descrição

    At risk Torsades de Pointes | Risk of sudden death | Prolonged QT interval Drug-induced | Bradycardia | Heart rate ECG | ECG abnormal | QTcF Prolongation ECG Quantity

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1444641
    UMLS CUI [1,2]
    C0040479
    UMLS CUI [2]
    C4014370
    UMLS CUI [3,1]
    C0151878
    UMLS CUI [3,2]
    C0458082
    UMLS CUI [4]
    C0428977
    UMLS CUI [5,1]
    C0018810
    UMLS CUI [5,2]
    C0013798
    UMLS CUI [6]
    C0522055
    UMLS CUI [7,1]
    C3828431
    UMLS CUI [7,2]
    C0013798
    UMLS CUI [7,3]
    C1265611
    the following cardiac conditions: sick sinus syndrome, complete av block, congestive heart failure, polymorphic ventricular tachycardia
    Descrição

    Heart Diseases | Sick Sinus Syndrome | Complete atrioventricular block | Congestive heart failure | Ventricular tachycardia, polymorphic

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0018799
    UMLS CUI [2]
    C0037052
    UMLS CUI [3]
    C0151517
    UMLS CUI [4]
    C0018802
    UMLS CUI [5]
    C0344432
    clinically relevant hypocalcemia, hypokalemia or hypomagnesemia
    Descrição

    Hypocalcemia | Hypokalemia | Hypomagnesemia

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0020598
    UMLS CUI [2]
    C0020621
    UMLS CUI [3]
    C0151723
    presence of congenital prolongation of the qt interval (romano-ward syndrome, jervell and lange-nielsen syndrome)
    Descrição

    Prolonged QT interval Congenital | Romano-Ward Syndrome | Jervell-Lange Nielsen Syndrome

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0151878
    UMLS CUI [1,2]
    C1744681
    UMLS CUI [2]
    C4551647
    UMLS CUI [3]
    C0022387
    history of any cancer, with the exception of basal cell carcinoma: clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center, in the opinion of the investigator
    Descrição

    Malignant Neoplasms | Exception Basal cell carcinoma | Hematology finding abnormal | Clinical Chemistry Finding Abnormal | Urinalysis abnormal

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0007117
    UMLS CUI [3]
    C0475182
    UMLS CUI [4,1]
    C2347783
    UMLS CUI [4,2]
    C0205161
    UMLS CUI [5]
    C0438142
    clinically significant abnormality on physical examination, in the opinion of the investigator
    Descrição

    Physical Examination Abnormal Finding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2826636
    at screening, has signs of orthostatic hypotension defined as a decrease in systolic ( > 20 mmhg) or diastolic (> 10 mmhg) blood pressure after standing for at least 2 minutes, that is associated with an increase in pulse rate of >15 bpm compared with supine measurements
    Descrição

    Signs Orthostatic Hypotension | Standing systolic blood pressure Decrease | Standing diastolic blood pressure Decrease | Pulse Rate Increase | Comparison Measurement Supine Position

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0311392
    UMLS CUI [1,2]
    C0020651
    UMLS CUI [2,1]
    C1303018
    UMLS CUI [2,2]
    C0547047
    UMLS CUI [3,1]
    C1303019
    UMLS CUI [3,2]
    C0547047
    UMLS CUI [4,1]
    C0232117
    UMLS CUI [4,2]
    C0442805
    UMLS CUI [5,1]
    C1707455
    UMLS CUI [5,2]
    C0242485
    UMLS CUI [5,3]
    C0038846
    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
    Descrição

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

    Tipo de dados

    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
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    Similar models

    Eligibility Schizophrenia NCT00791193

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Contraceptive methods | Sperm donation Absent
    Item
    must agree to use an efficient method of birth control as deemed appropriate by the investigator and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
    boolean
    C0700589 (UMLS CUI [1])
    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 | Pulse Rate
    Item
    blood pressure (after the volunteer is supine for 5 minutes) between 100 and 140 mmhg systolic, inclusive, and between 50 and 90 mmhg diastolic. pulse rate measured over 60 seconds should be between 40 and 100 beats per minute (bpm)
    boolean
    C1319895 (UMLS CUI [1])
    C1319896 (UMLS CUI [2])
    C0232117 (UMLS CUI [3])
    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])
    At risk Torsades de Pointes | Risk of sudden death | Prolonged QT interval Drug-induced | Bradycardia | Heart rate ECG | ECG abnormal | QTcF Prolongation ECG Quantity
    Item
    history or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the qtc interval, including: bradycardia (heart rate < 40 bpm on the ecg), clinically significant abnormality on the ecg, demonstration of repeated prolonged qtcf > 450 ms (qtc interval corrected for heart rate using fridericia's formula), as measured on more than one ecg (either during screening, or from prior medical record)
    boolean
    C1444641 (UMLS CUI [1,1])
    C0040479 (UMLS CUI [1,2])
    C4014370 (UMLS CUI [2])
    C0151878 (UMLS CUI [3,1])
    C0458082 (UMLS CUI [3,2])
    C0428977 (UMLS CUI [4])
    C0018810 (UMLS CUI [5,1])
    C0013798 (UMLS CUI [5,2])
    C0522055 (UMLS CUI [6])
    C3828431 (UMLS CUI [7,1])
    C0013798 (UMLS CUI [7,2])
    C1265611 (UMLS CUI [7,3])
    Heart Diseases | Sick Sinus Syndrome | Complete atrioventricular block | Congestive heart failure | Ventricular tachycardia, polymorphic
    Item
    the following cardiac conditions: sick sinus syndrome, complete av block, congestive heart failure, polymorphic ventricular tachycardia
    boolean
    C0018799 (UMLS CUI [1])
    C0037052 (UMLS CUI [2])
    C0151517 (UMLS CUI [3])
    C0018802 (UMLS CUI [4])
    C0344432 (UMLS CUI [5])
    Hypocalcemia | Hypokalemia | Hypomagnesemia
    Item
    clinically relevant hypocalcemia, hypokalemia or hypomagnesemia
    boolean
    C0020598 (UMLS CUI [1])
    C0020621 (UMLS CUI [2])
    C0151723 (UMLS CUI [3])
    Prolonged QT interval Congenital | Romano-Ward Syndrome | Jervell-Lange Nielsen Syndrome
    Item
    presence of congenital prolongation of the qt interval (romano-ward syndrome, jervell and lange-nielsen syndrome)
    boolean
    C0151878 (UMLS CUI [1,1])
    C1744681 (UMLS CUI [1,2])
    C4551647 (UMLS CUI [2])
    C0022387 (UMLS CUI [3])
    Malignant Neoplasms | Exception Basal cell carcinoma | Hematology finding abnormal | Clinical Chemistry Finding Abnormal | Urinalysis abnormal
    Item
    history of any cancer, with the exception of basal cell carcinoma: clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center, in the opinion of the investigator
    boolean
    C0006826 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0007117 (UMLS CUI [2,2])
    C0475182 (UMLS CUI [3])
    C2347783 (UMLS CUI [4,1])
    C0205161 (UMLS CUI [4,2])
    C0438142 (UMLS CUI [5])
    Physical Examination Abnormal Finding
    Item
    clinically significant abnormality on physical examination, in the opinion of the investigator
    boolean
    C2826636 (UMLS CUI [1])
    Signs Orthostatic Hypotension | Standing systolic blood pressure Decrease | Standing diastolic blood pressure Decrease | Pulse Rate Increase | Comparison Measurement Supine Position
    Item
    at screening, has signs of orthostatic hypotension defined as a decrease in systolic ( > 20 mmhg) or diastolic (> 10 mmhg) blood pressure after standing for at least 2 minutes, that is associated with an increase in pulse rate of >15 bpm compared with supine measurements
    boolean
    C0311392 (UMLS CUI [1,1])
    C0020651 (UMLS CUI [1,2])
    C1303018 (UMLS CUI [2,1])
    C0547047 (UMLS CUI [2,2])
    C1303019 (UMLS CUI [3,1])
    C0547047 (UMLS CUI [3,2])
    C0232117 (UMLS CUI [4,1])
    C0442805 (UMLS CUI [4,2])
    C1707455 (UMLS CUI [5,1])
    C0242485 (UMLS CUI [5,2])
    C0038846 (UMLS CUI [5,3])
    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])
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