Healthy adult
Item
1. Is the subject a healthy, male or female subject between 18 and 50 years of age (both inclusive)?
boolean
C0686750 (UMLS CUI [1])
BMI and weight
Item
2. Is the subject's body mass index of 19 to 29 kg/m^2, with a body weight ≥50 kg?
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Physical examination normal
Item
3. Is the subject healthy as judged by responsible physician and no abnormality identified on the clinical examination?
boolean
C0855737 (UMLS CUI [1])
Normal laboratory parameters
Item
4. Is the subject healthy as judged by resposible physician and no abnormality revealed by the clinical laboratory parameters examination at the pre-study medical examination?
boolean
C0438214 (UMLS CUI [1])
Normal 12-lead ECG
Item
5. Is the 12-lead ECG at the pre-study screening normal?
boolean
C0430456 (UMLS CUI [1,1])
C0459422 (UMLS CUI [1,2])
Normal systolic and diastolic blood pressure
Item
6. Does the subject have normal systolic (100-140 mmHg) and diastolic (<90 mmHg) blood pressure (semi-supine) at prestudy screening?
boolean
C0277882 (UMLS CUI [1])
C0277887 (UMLS CUI [2])
Written informed consent
Item
7. Does the subject give a written informed consent prior to admission to the study?
boolean
C0021430 (UMLS CUI [1])