Healthy Volunteers
Item
healthy subjects
boolean
C1708335 (UMLS CUI [1])
Age
Item
age ≥18 and ≤70 years
boolean
C0001779 (UMLS CUI [1])
Obesity Absent | Body mass index
Item
non-obese; body mass index between 18.0 and 30.0 kg/m2 inclusive.
boolean
C0028754 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1305855 (UMLS CUI [2])
General health good Medical History | General health good Physical Examination | General health good Biochemical finding
Item
considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the investigator.
boolean
C1277245 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1277245 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C1277245 (UMLS CUI [3,1])
C0428132 (UMLS CUI [3,2])
Non-smoker | Light tobacco smoker Number of cigarettes per day | Ability Refrain from Smoking
Item
non-smoker, or light smoker, defined as <15 cigarettes/day and able to abstain from smoking during confinement period.
boolean
C0337672 (UMLS CUI [1])
C3494624 (UMLS CUI [2,1])
C3694146 (UMLS CUI [2,2])
C0085732 (UMLS CUI [3,1])
C4086797 (UMLS CUI [3,2])
Pregnancy Absent | Breast Feeding Absent | Female Sterilization | Tubal Occlusion | Hysterectomy | Bilateral salpingectomy | Bilateral oophorectomy | Postmenopausal state Duration | Male sterilization | Gender Sexual Abstinence | Partner Childbearing Potential | Gender Contraceptive methods
Item
females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of study drug.
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0015787 (UMLS CUI [3])
C0041275 (UMLS CUI [4])
C0020699 (UMLS CUI [5])
C0195509 (UMLS CUI [6])
C0278321 (UMLS CUI [7])
C0232970 (UMLS CUI [8,1])
C0449238 (UMLS CUI [8,2])
C0024559 (UMLS CUI [9])
C0079399 (UMLS CUI [10,1])
C0036899 (UMLS CUI [10,2])
C0682323 (UMLS CUI [11,1])
C3831118 (UMLS CUI [11,2])
C0079399 (UMLS CUI [12,1])
C0700589 (UMLS CUI [12,2])
Informed Consent
Item
signed and dated informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject).
boolean
C0021430 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trials
Item
previous participation in this trial or other clinical trials within the last 3 months.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Haematology test abnormal | Abnormal Laboratory Result (Biochemistry) | Elevated liver enzymes | Healthy Volunteers | Diabetes Mellitus | Aspartate aminotransferase increased | Alanine aminotransferase increased | Renal Insufficiency | Serum creatinine raised
Item
clinically significant abnormal hematology or biochemistry screening tests, as judged by the investigator. in particular, healthy subjects with liver enzymes above the upper limit of the normal range and subjects with diabetes who have elevated liver enzymes (ast or alt >2 times the upper limit of normal) or impaired renal function (elevated serum creatinine values above the upper limit of normal) will be excluded.
boolean
C1112712 (UMLS CUI [1])
C0281768 (UMLS CUI [2])
C0235996 (UMLS CUI [3])
C1708335 (UMLS CUI [4])
C0011849 (UMLS CUI [5])
C0151904 (UMLS CUI [6])
C0151905 (UMLS CUI [7])
C1565489 (UMLS CUI [8])
C0700225 (UMLS CUI [9])
Illness Interferes with Research results | Illness Investigational New Drugs At risk | Cardiovascular Diseases | Anemia | Decreased hemoglobin | Hemoglobinopathy
Item
history of any illness that, in the opinion of the investigator, might confound the results of the trial or pose risk in administering the trial drug to the subject. in particular, subjects with significant cardiovascular disease, anemia (hemoglobin below the lower limit of normal) or hemoglobinopathy will not be allowed to enter the trial.
boolean
C0221423 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0221423 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0007222 (UMLS CUI [3])
C0002871 (UMLS CUI [4])
C1821769 (UMLS CUI [5])
C0019045 (UMLS CUI [6])
ECG abnormal
Item
clinically significant abnormal ecg at screening, as judged by the investigator.
boolean
C0522055 (UMLS CUI [1])
Alcohol abuse
Item
history of alcohol abuse.
boolean
C0085762 (UMLS CUI [1])
Drug abuse Positive
Item
any positive reaction of drugs of abuse.
boolean
C0013146 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Hepatitis B positive | Hepatitis C positive | HIV Seropositivity
Item
hepatitis b or c or hiv positive.
boolean
C0856706 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Prescription Drugs | Exception Pharmaceutical Preparations Study Protocol
Item
use of prescription drugs within 3 weeks preceding the first dosing of insulin, except for medications deemed acceptable per protocol specific list of concomitant medications.
boolean
C0304227 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])