bmi
Item
body mass index ( weight [kg]/height [m2]) of 18 to 30 kg/m2, inclusive
boolean
C1305855 (UMLS CUI [1])
blood pressure supine
Item
have a supine (after 5 minutes rest) blood pressure between 100 and 140 mmhg systolic, inclusive, and 50 and 90 mmhg diastolic, inclusive
boolean
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
physical examination | Medical History | 12 lead ECG | Laboratory Results; Serum Chemistry Measurement; Hematology finding; Urinalysis | Renal function
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 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
C0031809 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0430456 (UMLS CUI [3])
C1254595 (UMLS CUI [4,1])
C1883010 (UMLS CUI [4,2])
C0474523 (UMLS CUI [4,3])
C0042014 (UMLS CUI [4,4])
C0232804 (UMLS CUI [5])
hypersensitivity risperidone, paliperidone
Item
known drug allergy to risperidone, paliperidone, or any of its excipients
boolean
C0020517 (UMLS CUI [1,1])
C0073393 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0753678 (UMLS CUI [2,2])
drug-induced dystonia
Item
known history of drug-induced dystonia
boolean
C0393595 (UMLS CUI [1])
substance use disorder
Item
recent history of alcohol or substance abuse
boolean
C0038586 (UMLS CUI [1])
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
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
C0018799 (UMLS CUI [1,1])
C0027051 (UMLS CUI [1,2])
C0003811 (UMLS CUI [1,3])
C0024115 (UMLS CUI [2])
C0027765 (UMLS CUI [3,1])
C0036572 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0023895 (UMLS CUI [6])
C0017178 (UMLS CUI [7,1])
C0524722 (UMLS CUI [7,2])
C0521587 (UMLS CUI [7,3])
C0024523 (UMLS CUI [7,4])
C0014130 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0021053 (UMLS CUI [10])
history of any cancer, with the exception of basal cell carcinoma
Item
history of any cancer, with the exception of basal cell carcinoma
boolean
C2735088 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
autonomic dysfunction, Systolic Pressure; Diastolic blood pressure; Standing position; heart rate
Item
at screening, has signs of autonomic dysfunction as indicated by a sustained decrease of > 20 mmhg in systolic blood pressure or a decrease of >10 mmhg in diastolic blood pressure after standing for at least 2 minutes that is not associated with an increase of >15 beats per minute (bpm) in heart rate
boolean
C1145628 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
C0428883 (UMLS CUI [1,3])
C0018810 (UMLS CUI [1,4])
C0231472 (UMLS CUI [1,5])
bradycardia as determined by screening 12-lead ecg
Item
bradycardia (heart rate <50 bpm) as determined by screening 12-lead ecg
boolean
C0428977 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
hiv, hep b, hep c
Item
a positive test result (or history of) for any of the serology tests (hepatitis b and c, and human immunodeficiency virus) at screening
boolean
C0019682 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0019196 (UMLS CUI [1,3])
tobacco use
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])
drugs and supplements, paracetamol, ibuprofen
Item
use of any prescription or nonprescription medication (including vitamins and herbal supplements) within 14 days before the first dose of study drug. exception for acetaminophen (paracetamol) or ibuprofen, which is allowed up to 3 days before first dose of study drug
boolean
C0013227 (UMLS CUI [1,1])
C0242295 (UMLS CUI [1,2])
C0000970 (UMLS CUI [2])
C0020740 (UMLS CUI [3])