Healhty, Sex, Age
Item
Is the subject a healthy, male or female subject between 18 and 50 years of age (both inclusive)?
boolean
C3898900 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
BMI and weight
Item
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
Is the subject healthy as judged by responsible physician and no abnormality identified on the clinical examination?
boolean
C1708335 (UMLS CUI [1,1])
C0855737 (UMLS CUI [1,2])
Normal laboratory parameters
Item
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
C1708335 (UMLS CUI [1,1])
C0438214 (UMLS CUI [1,2])
Normal 12-lead ECG
Item
Is the 12-lead ECG at the pre-study screening normal?
boolean
C0430456 (UMLS CUI [1,1])
C0459422 (UMLS CUI [1,2])
Normal blood pressure
Item
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
Does the subject give a written informed consent prior to admission to the study?
boolean
C0021430 (UMLS CUI [1])
Adverse reaction to study drug
Item
1. Does the subject have a definite or suspected personal history or family history of adverse reactions or hypersensitivity to the study drug or to drugs with a similar chemical structure?
boolean
C0559546 (UMLS CUI [1,1])
C0241889 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0241889 (UMLS CUI [2,2])
Abnormality of organs or blood
Item
2. Does the subject have a history or presence of clinically significant cardiovascular, neurological, psychiatric, haemotological or renal abnormalities?
boolean
C0243050 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0475182 (UMLS CUI [4])
C0151746 (UMLS CUI [5])
Postural hypotension or faints
Item
3. Does the subject have a history of postural hypotension or faints?
boolean
C0020651 (UMLS CUI [1])
C0039070 (UMLS CUI [2])
Gastrointestinal, hepatic or renal disease
Item
4. Does the subject have a history or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs?
boolean
C0017178 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C1512073 (UMLS CUI [4])
Subject's medication
Item
5. Has the subject received prescribed medication (including the oral contraceptive pill and hormone replacement therapy) within 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day, which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subject's safety?
boolean
C3166216 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C0013231 (UMLS CUI [2,1])
C0687133 (UMLS CUI [2,2])
Drugs with effect on CYP1A2
Item
6. Has the subject withdrawn, introduced, or changed the dose of any drug known to substantially inhibit CYP 1A2 (e.g., ciprofloxacin, fluvoxarnine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to first day of dosing?
boolean
C1827490 (UMLS CUI [1])
C0919438 (UMLS CUI [2,1])
C0207509 (UMLS CUI [2,2])
Alcohol abuse
Item
7. Does the subject have an abuse of alcohol, defined as an average weekly intake of greater than 21 units or an average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women?
boolean
C0085762 (UMLS CUI [1])
Other clinical trial, blood donation or blood loss
Item
8. Has the subject participated in another clinical trial, blood donation or has the subject lost blood less than 90 days before the present study?
boolean
C0679823 (UMLS CUI [1,1])
C1516648 (UMLS CUI [1,2])
C0005794 (UMLS CUI [2])
C3163616 (UMLS CUI [3])
Hepatitis B, C or HIV antibodies
Item
9. Does the subject have a positive pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies?
boolean
C0149708 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C2697540 (UMLS CUI [3,1])
C0741132 (UMLS CUI [3,2])
Pregnant or breast-feeding
Item
10. Is the subject pregnant and/or breast-feeding?
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
No contraception
Item
11. Is the subject a female of child-bearing potential who is not practising a clinically accepted method of contraception such as surgical sterilisation, 1.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant)?
boolean
C3831118 (UMLS CUI [1,1])
C0445107 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Positive pregnancy test
Item
12. Is the subject a female with positive urine/serum pregnancy test result at screening?
boolean
C0430059 (UMLS CUI [1])
C0425986 (UMLS CUI [2])