0 Evaluaciones
ID

32130

Descripción

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

Palabras clave

Versiones (2)
  1. 20/10/18 20/10/18 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de octubre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

  • El más nuevo
  • Más antiguo
  • Popular
  • El más nuevo
    • El más nuevo
    • Más antiguo
    • Popular

    Sin comentarios

    Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

    Eligibility Schizophrenia NCT00791193

    Inglés

    Eligibility Schizophrenia NCT00791193

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    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
    Descripción

    Contraceptive methods | Sperm donation Absent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    UMLS CUI [2,1]
    C0871414 (Sperm donation)
    UMLS CUI [2,2]
    C0332197 (Absent)
    SNOMED
    2667000
    LOINC
    LA9634-2
    body mass index (weight [kg]/height [m2]) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
    Descripción

    Body mass index | Body Weight

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1305855 (Body mass index)
    SNOMED
    60621009
    LOINC
    LP35925-4
    UMLS CUI [2]
    C0005910 (Body Weight)
    SNOMED
    27113001
    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)
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1319895 (Lying systolic blood pressure)
    SNOMED
    407556006
    UMLS CUI [2]
    C1319896 (Lying diastolic blood pressure)
    SNOMED
    407557002
    UMLS CUI [3]
    C0232117 (Pulse Rate)
    SNOMED
    78564009
    non-smoker
    Descripción

    Non-smoker

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0337672 (Non-smoker)
    SNOMED
    8392000
    Exclusion Criteria
    Descripción

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    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
    Descripción

    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 datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423 (Illness (finding))
    SNOMED
    39104002
    UMLS CUI [1,2]
    C0750502 (Significant)
    SNOMED
    386134007
    LOINC
    LA28474-7
    UMLS CUI [2]
    C0003811 (Cardiac Arrhythmia)
    SNOMED
    698247007
    LOINC
    LA7414-1
    UMLS CUI [3]
    C0018799 (Heart Diseases)
    SNOMED
    56265001
    UMLS CUI [4]
    C0018939 (Hematological Disease)
    SNOMED
    34093004
    UMLS CUI [5]
    C0005779 (Blood Coagulation Disorders)
    SNOMED
    64779008
    UMLS CUI [6]
    C1458140 (Bleeding tendency)
    SNOMED
    64779008
    LOINC
    LA20352-3
    UMLS CUI [7]
    C0549634 (Lipids abnormal)
    SNOMED
    166818002
    UMLS CUI [8]
    C0024115 (Lung diseases)
    SNOMED
    19829001
    UMLS CUI [9,1]
    C0006266 (Bronchospasm)
    SNOMED
    4386001
    UMLS CUI [9,2]
    C0332281 (Associated with)
    SNOMED
    47429007
    UMLS CUI [9,3]
    C0035204 (Respiration Disorders)
    SNOMED
    50043002
    LOINC
    LA20369-7
    UMLS CUI [10]
    C0011849 (Diabetes Mellitus)
    SNOMED
    73211009
    UMLS CUI [11]
    C1565489 (Renal Insufficiency)
    SNOMED
    236423003
    UMLS CUI [12]
    C1306571 (Hepatic Insufficiency)
    UMLS CUI [13]
    C0040128 (Thyroid Diseases)
    SNOMED
    14304000
    UMLS CUI [14]
    C0027765 (nervous system disorder)
    SNOMED
    118940003
    LOINC
    LA10590-0
    UMLS CUI [15]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [16]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    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)
    Descripción

    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 datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1444641 (At risk)
    SNOMED
    410519009
    LOINC
    LA19952-3
    UMLS CUI [1,2]
    C0040479 (Torsades de Pointes)
    SNOMED
    31722008
    UMLS CUI [2]
    C4014370 (undefined)
    UMLS CUI [3,1]
    C0151878 (Prolonged QT interval)
    SNOMED
    111975006
    UMLS CUI [3,2]
    C0458082 (Drug-induced)
    SNOMED
    278993004
    UMLS CUI [4]
    C0428977 (Bradycardia)
    SNOMED
    48867003
    LOINC
    LA17394-0
    UMLS CUI [5,1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    UMLS CUI [5,2]
    C0013798 (Electrocardiogram)
    LOINC
    LP149975-7
    UMLS CUI [6]
    C0522055 (Electrocardiogram abnormal (finding))
    SNOMED
    102594003
    LOINC
    LA24621-7
    UMLS CUI [7,1]
    C3828431 (QTcF Prolongation)
    UMLS CUI [7,2]
    C0013798 (Electrocardiogram)
    LOINC
    LP149975-7
    UMLS CUI [7,3]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    the following cardiac conditions: sick sinus syndrome, complete av block, congestive heart failure, polymorphic ventricular tachycardia
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0018799 (Heart Diseases)
    SNOMED
    56265001
    UMLS CUI [2]
    C0037052 (Sick Sinus Syndrome)
    SNOMED
    36083008
    UMLS CUI [3]
    C0151517 (Complete atrioventricular block)
    SNOMED
    27885002
    LOINC
    LA17089-6
    UMLS CUI [4]
    C0018802 (Congestive heart failure)
    SNOMED
    42343007
    LOINC
    MTHU020787
    UMLS CUI [5]
    C0344432 (Ventricular tachycardia, polymorphic)
    SNOMED
    251159007
    clinically relevant hypocalcemia, hypokalemia or hypomagnesemia
    Descripción

    Hypocalcemia | Hypokalemia | Hypomagnesemia

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0020598 (Hypocalcemia)
    SNOMED
    5291005
    UMLS CUI [2]
    C0020621 (Hypokalemia)
    SNOMED
    43339004
    LOINC
    LA15423-9
    UMLS CUI [3]
    C0151723 (Hypomagnesemia)
    SNOMED
    190855004
    presence of congenital prolongation of the qt interval (romano-ward syndrome, jervell and lange-nielsen syndrome)
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0151878 (Prolonged QT interval)
    SNOMED
    111975006
    UMLS CUI [1,2]
    C1744681 (Congenital qualifier)
    SNOMED
    255399007
    LOINC
    LA24667-0
    UMLS CUI [2]
    C0035828 (undefined)
    UMLS CUI [3]
    C0022387 (Jervell-Lange Nielsen Syndrome)
    SNOMED
    373905003
    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
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    UMLS CUI [2,1]
    C1705847 (Exception - Property or Attribute)
    UMLS CUI [2,2]
    C0007117 (Basal cell carcinoma)
    SNOMED
    1338007
    UMLS CUI [3]
    C0475182 (Hematology finding abnormal)
    SNOMED
    309194008
    UMLS CUI [4,1]
    C2347783 (Clinical Chemistry Finding)
    UMLS CUI [4,2]
    C0205161 (Abnormal)
    SNOMED
    263654008
    LOINC
    LP28764-6
    UMLS CUI [5]
    C0438142 (Urine screening abnormal)
    SNOMED
    167222005
    clinically significant abnormality on physical examination, in the opinion of the investigator
    Descripción

    Physical Examination Abnormal Finding

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2826636 (Physical Examination Abnormal Finding)
    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
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0311392 (Physical findings)
    SNOMED
    72670004
    LOINC
    LP73100-7
    UMLS CUI [1,2]
    C0020651 (Hypotension, Orthostatic)
    SNOMED
    28651003
    UMLS CUI [2,1]
    C1303018 (Standing systolic blood pressure)
    SNOMED
    400974009
    UMLS CUI [2,2]
    C0547047 (Decrease)
    SNOMED
    260370003
    UMLS CUI [3,1]
    C1303019 (Standing diastolic blood pressure)
    SNOMED
    400975005
    UMLS CUI [3,2]
    C0547047 (Decrease)
    SNOMED
    260370003
    UMLS CUI [4,1]
    C0232117 (Pulse Rate)
    SNOMED
    78564009
    UMLS CUI [4,2]
    C0442805 (Increase)
    SNOMED
    260366006
    UMLS CUI [5,1]
    C1707455 (Comparison)
    LOINC
    LP76241-6
    UMLS CUI [5,2]
    C0242485 (Measurement)
    SNOMED
    272391002
    LOINC
    LP7412-2
    UMLS CUI [5,3]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    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
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0304227 (Prescription Drugs)
    UMLS CUI [2]
    C0013231 (Drugs, Non-Prescription)
    UMLS CUI [3]
    C0042890 (Vitamins)
    SNOMED
    87708000
    LOINC
    LP31395-4
    UMLS CUI [4]
    C1504473 (Herbal Supplements)
    UMLS CUI [5,1]
    C1705847 (Exception - Property or Attribute)
    UMLS CUI [5,2]
    C0000970 (acetaminophen)
    SNOMED
    90332006
    UMLS CUI [6,1]
    C1705847 (Exception - Property or Attribute)
    UMLS CUI [6,2]
    C0020740 (ibuprofen)
    SNOMED
    38268001
    Volver a la parte superior de la página

    Similar models

    Eligibility Schizophrenia NCT00791193

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    C0035828 (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])
    Volver a la parte superior de la página 

    Ayuda

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial