ID

23094

Description

A Study of the Effect of Food and Posture on the Pharmacokinetics of a Single Dose of ER OROS Paliperidone; ODM derived from: https://clinicaltrials.gov/show/NCT00838669

Link

https://clinicaltrials.gov/show/NCT00838669

Keywords

Versions (2)
  1. 6/23/17 6/23/17 -
  2. 6/23/17 6/23/17 -
Uploaded on

June 23, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Schizophrenia NCT00838669

English

Eligibility Schizophrenia NCT00838669

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
body mass index (weight [kg]/height [m2]) of 18 to 30 kg/m2, inclusive
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
a supine (after 5 minutes rest) blood pressure between 100 and 140 mmhg systolic, inclusive, and 50 and 90 mmhg diastolic, inclusive
Description

Lying systolic blood pressure | Lying diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1319895
UMLS CUI [2]
C1319896
healthy on the basis of a prestudy physical examination, medical history, 12-lead ecg, and the laboratory results of serum chemistry, hematology, and urinalysis performed within 21 days before the first dose. if the results of the serum chemistry, hematology, or urinalysis testing are not within the laboratory's reference ranges, the male volunteer can be included only if the investigator judges that the deviations are not clinically significant. for renal function tests, the values must be within the normal laboratory reference ranges.
Description

Healthy Volunteers | Physical Examination Pre-study | Medical History | 12 lead ECG | Serum chemistry test | Hematology procedure | Urinalysis | Reference laboratory Within reference range | Kidney Function Tests

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C1527048
UMLS CUI [3]
C0262926
UMLS CUI [4]
C0430456
UMLS CUI [5]
C0236613
UMLS CUI [6]
C0200627
UMLS CUI [7]
C0042014
UMLS CUI [8,1]
C1532342
UMLS CUI [8,2]
C0460094
UMLS CUI [9]
C0022662
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
known drug allergy to risperidone, paliperidone, or any of its excipients
Description

Risperidone allergy | Hypersensitivity Paliperidone | Hypersensitivity Risperidone Excipient | Hypersensitivity Paliperidone Excipient

Data type

boolean

Alias
UMLS CUI [1]
C0570837
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0753678
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0073393
UMLS CUI [3,3]
C0015237
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0753678
UMLS CUI [4,3]
C0015237
known history of drug-induced dystonia
Description

Drug-induced dystonia

Data type

boolean

Alias
UMLS CUI [1]
C0393595
known allergy or history of significant hypersensitivity to heparin, if a heparin lock will be used
Description

Heparin allergy | Heparin lock flush

Data type

boolean

Alias
UMLS CUI [1]
C0571776
UMLS CUI [2]
C0720846
recent history of alcohol or substance abuse, a positive test result for the urine drug screen at screening or upon admittance to the testing facility, a positive result for the alcohol urine test upon admittance to the testing facility
Description

Substance Use Disorders | Urine drug screen positive | Urine alcohol test positive

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0743300
UMLS CUI [3]
C1112219
relevant history or presence of any cardiovascular (including myocardial infarct or cardiac arrhythmia), respiratory, neurologic (including seizures), psychiatric, renal, hepatic, gastrointestinal (including surgeries, severe gastrointestinal narrowing, and malabsorption problems), endocrine, hematologic, or immunologic disease
Description

Cardiovascular Diseases | Myocardial Infarction | Cardiac Arrhythmia | Respiration Disorders | nervous system disorder | Seizures | Mental disorders | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Gastrointestinal Surgical Procedure | Gastrointestinal stenosis Severe | Malabsorption conditions | Endocrine System Diseases | Hematological Disease | Immune System Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0003811
UMLS CUI [4]
C0035204
UMLS CUI [5]
C0027765
UMLS CUI [6]
C0036572
UMLS CUI [7]
C0004936
UMLS CUI [8]
C0022658
UMLS CUI [9]
C0023895
UMLS CUI [10]
C0017178
UMLS CUI [11]
C0524722
UMLS CUI [12,1]
C0521587
UMLS CUI [12,2]
C0205082
UMLS CUI [13]
C0851559
UMLS CUI [14]
C0014130
UMLS CUI [15]
C0018939
UMLS CUI [16]
C0021053
history of any cancer, with the exception of basal cell carcinomas
Description

Malignant Neoplasms | Basal cell carcinoma Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C2828389
history of smoking or use of nicotine-containing substances within the last 2 months, as determined by medical history and/or volunteer's verbal report. volunteers must agree to refrain from use throughout the study
Description

Tobacco use | Substance Nicotine Containing

Data type

boolean

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

Eligibility Schizophrenia NCT00838669

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Body mass index
Item
body mass index (weight [kg]/height [m2]) of 18 to 30 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
Lying systolic blood pressure | Lying diastolic blood pressure
Item
a supine (after 5 minutes rest) blood pressure between 100 and 140 mmhg systolic, inclusive, and 50 and 90 mmhg diastolic, inclusive
boolean
C1319895 (UMLS CUI [1])
C1319896 (UMLS CUI [2])
Healthy Volunteers | Physical Examination Pre-study | Medical History | 12 lead ECG | Serum chemistry test | Hematology procedure | Urinalysis | Reference laboratory Within reference range | Kidney Function Tests
Item
healthy on the basis of a prestudy physical examination, medical history, 12-lead ecg, and the laboratory results of serum chemistry, hematology, and urinalysis performed within 21 days before the first dose. if the results of the serum chemistry, hematology, or urinalysis testing are not within the laboratory's reference ranges, the male volunteer can be included only if the investigator judges that the deviations are not clinically significant. for renal function tests, the values must be within the normal laboratory reference ranges.
boolean
C1708335 (UMLS CUI [1])
C0031809 (UMLS CUI [2,1])
C1527048 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3])
C0430456 (UMLS CUI [4])
C0236613 (UMLS CUI [5])
C0200627 (UMLS CUI [6])
C0042014 (UMLS CUI [7])
C1532342 (UMLS CUI [8,1])
C0460094 (UMLS CUI [8,2])
C0022662 (UMLS CUI [9])
Item Group
C0680251 (UMLS CUI)
Risperidone allergy | Hypersensitivity Paliperidone | Hypersensitivity Risperidone Excipient | Hypersensitivity Paliperidone Excipient
Item
known drug allergy to risperidone, paliperidone, or any of its excipients
boolean
C0570837 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0753678 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0073393 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0753678 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
Drug-induced dystonia
Item
known history of drug-induced dystonia
boolean
C0393595 (UMLS CUI [1])
Heparin allergy | Heparin lock flush
Item
known allergy or history of significant hypersensitivity to heparin, if a heparin lock will be used
boolean
C0571776 (UMLS CUI [1])
C0720846 (UMLS CUI [2])
Substance Use Disorders | Urine drug screen positive | Urine alcohol test positive
Item
recent history of alcohol or substance abuse, a positive test result for the urine drug screen at screening or upon admittance to the testing facility, a positive result for the alcohol urine test upon admittance to the testing facility
boolean
C0038586 (UMLS CUI [1])
C0743300 (UMLS CUI [2])
C1112219 (UMLS CUI [3])
Cardiovascular Diseases | Myocardial Infarction | Cardiac Arrhythmia | Respiration Disorders | nervous system disorder | Seizures | Mental disorders | Kidney Diseases | Liver diseases | Gastrointestinal Diseases | Gastrointestinal Surgical Procedure | Gastrointestinal stenosis Severe | Malabsorption conditions | Endocrine System Diseases | Hematological Disease | Immune System Diseases
Item
relevant history or presence of any cardiovascular (including myocardial infarct or cardiac arrhythmia), respiratory, neurologic (including seizures), psychiatric, renal, hepatic, gastrointestinal (including surgeries, severe gastrointestinal narrowing, and malabsorption problems), endocrine, hematologic, or immunologic disease
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
C0035204 (UMLS CUI [4])
C0027765 (UMLS CUI [5])
C0036572 (UMLS CUI [6])
C0004936 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0023895 (UMLS CUI [9])
C0017178 (UMLS CUI [10])
C0524722 (UMLS CUI [11])
C0521587 (UMLS CUI [12,1])
C0205082 (UMLS CUI [12,2])
C0851559 (UMLS CUI [13])
C0014130 (UMLS CUI [14])
C0018939 (UMLS CUI [15])
C0021053 (UMLS CUI [16])
Malignant Neoplasms | Basal cell carcinoma Excluded
Item
history of any cancer, with the exception of basal cell carcinomas
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Tobacco use | Substance Nicotine Containing
Item
history of smoking or use of nicotine-containing substances within the last 2 months, as determined by medical history and/or volunteer's verbal report. volunteers must agree to refrain from use throughout the study
boolean
C0543414 (UMLS CUI [1])
C0439861 (UMLS CUI [2,1])
C0028040 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
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