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 | 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])
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])
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])