Gender, Age
Item
Healthy, male and female subjects between 18 and 65 years of age inclusive.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body mass index
Item
Body mass index of 19 to 29kg/m^2 , with a body weight of at least 50kg.
boolean
C1305855 (UMLS CUI [1])
No abnormality on clinical examination
Item
No abnormality on clinical examination.
boolean
C0559229 (UMLS CUI [1,1])
C1456356 (UMLS CUI [1,2])
No abnormal laboratory parameters
Item
No abnormality revealed by the clinical laboratory parameters examination at the pre-study medical examination.
boolean
C1298908 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
12-lead ECG
Item
A normal 12-lead ECG at the pre-study screening.
boolean
C0430456 (UMLS CUI [1])
Normal blood pressure
Item
Normal systolic (100-140mmHg) and diastolic (<90mmHg) blood pressure (Supine) at pre-study screening and pre-dose Day 1.
boolean
C0005823 (UMLS CUI [1])
Informed consent
Item
Written informed consent prior to admission to the study.
boolean
C0021430 (UMLS CUI [1])
Number of cigarettes per day
Item
Subjects who smoke more than 10 cigarettes per day.
boolean
C3694146 (UMLS CUI [1])
Comorbidity cardiovascular, neurological, psychiatric, haematological or renal
Item
History or presence of clinically significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities.
boolean
C0009488 (UMLS CUI [1,1])
C3887460 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0746866 (UMLS CUI [2,2])
C0009488 (UMLS CUI [3,1])
C0846574 (UMLS CUI [3,2])
C0009488 (UMLS CUI [4,1])
C0279810 (UMLS CUI [4,2])
C0009488 (UMLS CUI [5,1])
C0232804 (UMLS CUI [5,2])
Postural hypotension, faints
Item
History of postural hypotension or faints.
boolean
C0020651 (UMLS CUI [1,1])
C0039070 (UMLS CUI [1,2])
Comorbidity Interferes with drug metabolism
Item
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
C0009488 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
Medication
Item
The subject has received prescribed medication within 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day (apart from medications that are described below), which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subjects’ safety.
boolean
C0013227 (UMLS CUI [1])
Item
Women on HRT treatments during which the proportions of oestrogen and progesterone are not kept constant throughout their 28-day cycle. e.g. some cyclic HRT treatments.
text
C0279025 (UMLS CUI [1])
Code List
Women on HRT treatments during which the proportions of oestrogen and progesterone are not kept constant throughout their 28-day cycle. e.g. some cyclic HRT treatments.
drug dose
Item
7. Withdrawal, introduction, or change in dose of any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, fluvoxamine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to first day of dosing. Subjects who are on stable doses (no change within 7 days of 1 st dose) of any CYP1A2 medications are permitted to participate, if, in the opinion of the Principal investigator and in agreement with the Sponsor, the medication received will not interfere with the study procedures or compromise subjects’ safety.
boolean
C0678766 (UMLS CUI [1])
Item
Pregnancy and/or breast-feeding.
text
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Code List
Pregnancy and/or breast-feeding.
Item
Females of child-bearing potential who are not practicing a clinically accepted method of contraception such as surgical sterilization, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant ® ).
text
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Code List
Females of child-bearing potential who are not practicing a clinically accepted method of contraception such as surgical sterilization, I.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant ® ).
Item
Female subjects with positive urine/serum pregnancy test result at screening or prior to first dose.
text
C0240802 (UMLS CUI [1])
Code List
Female subjects with positive urine/serum pregnancy test result at screening or prior to first dose.
Substance use disorder
Item
Recent history (within the last 6 months), or suspicion, of drug dependence or a positive screening or pre-dose drugs of abuse screen.
boolean
C0038586 (UMLS CUI [1])
Alcohol abuse
Item
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])
Hepatitis B surface antigen hepatitis C antibody positive; HIV Antibodies
Item
Positive pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies.
boolean
C0019168 (UMLS CUI [1,1])
C0281863 (UMLS CUI [1,2])
C0019683 (UMLS CUI [2])
Study subject participation status; blood donation
Item
Participation in another clinical trial, blood donation or blood loss less than 90 days before the present study.
boolean
C2348568 (UMLS CUI [1])
C0005794 (UMLS CUI [2])
Hypersensitivity
Item
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
C0020517 (UMLS CUI [1])