Healthy Volunteers Medical History | Healthy Volunteers Physical Examination | Healthy Volunteers Vital signs | Healthy Volunteers 12 lead ECG | Healthy Volunteers Laboratory Procedures
Item
healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination (pe), vital signs, 12-lead ecg, and clinical laboratory determinations
boolean
C1708335 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1708335 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C1708335 (UMLS CUI [3,1])
C0518766 (UMLS CUI [3,2])
C1708335 (UMLS CUI [4,1])
C0430456 (UMLS CUI [4,2])
C1708335 (UMLS CUI [5,1])
C0022885 (UMLS CUI [5,2])
Body mass index
Item
body mass index (bmi) of 18.5 to 30 kg/m(2)
boolean
C1305855 (UMLS CUI [1])
Age
Item
men and women, ages 18 to 50 years
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential must use acceptable methods of highly effective birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Illness | Chronic disease
Item
any significant acute or chronic medical illness
boolean
C0221423 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
Gastrointestinal Disease
Item
current or recent gastrointestinal disease
boolean
C0017178 (UMLS CUI [1])
Major surgery
Item
any major surgery within 4 weeks of study drug administration
boolean
C0679637 (UMLS CUI [1])
Chronic urinary tract infection | Recurrent urinary tract infection | Gender
Item
history of chronic or recurrent urinary tract infection for females
boolean
C0262421 (UMLS CUI [1])
C0262655 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Glucose intolerance | Diabetes Mellitus
Item
history of glucose intolerance or diabetes mellitus
boolean
C0271650 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
Hypersensitivity Dipeptidyl-Peptidase IV Inhibitors | Adverse reactions Dipeptidyl-Peptidase IV Inhibitors | Hypersensitivity Sodium-Glucose Transporter Inhibitors | Adverse reactions Sodium-Glucose Transporter Inhibitors
Item
history of allergies or adverse reactions to dipeptidyl peptidase-iv (dpp4) or sodium-glucose cotransporter (sglt) inhibitors
boolean
C0020517 (UMLS CUI [1,1])
C1827106 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C1827106 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C3665045 (UMLS CUI [3,2])
C0559546 (UMLS CUI [4,1])
C3665045 (UMLS CUI [4,2])
Exposure to Saxagliptin | Exposure to Dapagliflozin | Exposure to Pharmaceutical Preparations Related
Item
prior exposure to saxagliptin or dapagliflozin or related drugs
boolean
C0332157 (UMLS CUI [1,1])
C1611934 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C2353951 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])