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 septembre 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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