Healthy Volunteers | Pregnancy | Breast Feeding
Item
healthy male and female volunteers (female not pregnant, lactating or breastfeeding)
boolean
C1708335 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Body mass index | Gender
Item
bmi (body mass index) between 19-29 kg/m^2, both inclusive
boolean
C1305855 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Plasma fasting glucose measurement
Item
fasting plasma glucose from 70-115 mg/dl
boolean
C0583513 (UMLS CUI [1])
Study Subject Good health | Medical History | Physical Examination | Electrocardiography | Laboratory test finding
Item
subject is judged to be in good health on the basis of their medical history, physical examination, ecg (electrocardiogram), and routine laboratory data
boolean
C0681850 (UMLS CUI [1,1])
C3813622 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C1623258 (UMLS CUI [4])
C0587081 (UMLS CUI [5])
Systemic disease | Disease body organ
Item
any clinically significant disease history, in the opinion of the investigator, of systemic or organ disease
boolean
C0442893 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1280836 (UMLS CUI [2,2])
Abnormality Physical Examination | Laboratory test result abnormal
Item
clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening
boolean
C1704258 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2])
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive
Item
positive results on screening for hepatitis b surface antigen, hepatitis c antibody and hiv (human immunodeficiency virus) antibody
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0920548 (UMLS CUI [3])
Drug screen positive | Blood alcohol test positive
Item
positive results on the drug abuse/alcohol screen
boolean
C0743295 (UMLS CUI [1])
C0948726 (UMLS CUI [2])
Pharmaceutical Preparations Regular | Non-Prescription Drugs Regular | Megavitamin Therapy | Herbal supplement | Contraceptive Agents To be stopped
Item
any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens, other than contraceptives, that cannot be stopped at least 1 week prior to visit 2 (trial product dose administration) and for the duration of the study
boolean
C0013227 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0013231 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0029340 (UMLS CUI [3])
C1504473 (UMLS CUI [4])
C0009871 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
Tobacco use Number of cigarettes per day
Item
subject is currently a smoker (more than one cigarette per day or equivalent)
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Grapefruit | GRAPEFRUIT JUICE
Item
use of grapefruit or grapefruit juice within 7 days of trial product dose administration
boolean
C0995150 (UMLS CUI [1])
C0452456 (UMLS CUI [2])
Blood Donation | Operative Surgical Procedure Blood Loss | Trauma Blood Loss
Item
blood donation, surgery or trauma with significant blood loss (500 ml) within the last 2 months prior to dosing
boolean
C0005794 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C3163616 (UMLS CUI [2,2])
C3714660 (UMLS CUI [3,1])
C3163616 (UMLS CUI [3,2])