Informed Consent
Item
1. signed informed consent form
boolean
C0021430 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's irb or iec before the initiation of any protocol-required procedures.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Target Population
Item
2. target population
boolean
C0039309 (UMLS CUI [1])
Healthy Volunteers | Medical History Normal | Psychiatric History Normal | Physical examination normal | Normal vital signs | 12 lead ECG Normal | Physical measurements Normal | Normal Laboratory Test Result
Item
healthy subjects as determined by no clinically significant deviation from normal in medical history, psychiatric history, physical examination findings, vital sign measurements, 12-lead ecg measurements, physical measurements, and clinical laboratory test results.
boolean
C1708335 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0748059 (UMLS CUI [3,1])
C0205307 (UMLS CUI [3,2])
C0855737 (UMLS CUI [4])
C0277803 (UMLS CUI [5])
C0430456 (UMLS CUI [6,1])
C0205307 (UMLS CUI [6,2])
C0695448 (UMLS CUI [7,1])
C0205307 (UMLS CUI [7,2])
C0438214 (UMLS CUI [8])
Age | Reproduction Status
Item
3. age and reproductive status
boolean
C0001779 (UMLS CUI [1])
C0035150 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
Age
Item
males and females, ages 19 to 55 years, inclusive. to extent possible, the distribution of men and women between the sequences will be balanced
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative | hCG measurement
Item
women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test (minimum sensitivity 25 iu/l or equivalent units of hcg) within 24 hours prior to the start of study drug.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C0428402 (UMLS CUI [3])
Gender | Breast Feeding Absent
Item
women must not be breastfeeding.
boolean
C0079399 (UMLS CUI [1])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Illness | Chronic disease
Item
any significant acute or chronic medical illness.
boolean
C0221423 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
Gastrointestinal Disease Impact Absorption Investigational New Drug
Item
current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
boolean
C0017178 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
Major surgery
Item
any major surgery within 4 weeks of study drug administration.
boolean
C0679637 (UMLS CUI [1])
Tobacco use | Use of Nicotine product
Item
use of tobacco- or nicotine- containing products within 6 months before check-in
boolean
C0543414 (UMLS CUI [1])
C1524063 (UMLS CUI [2,1])
C0028040 (UMLS CUI [2,2])
Cause Medical | Cause Psychiatric | Cause social
Item
any other sound medical, psychiatric, and/or social reason as determined by the investigator.
boolean
C0015127 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0205487 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0728831 (UMLS CUI [3,2])