Healthy Volunteers | Age | Body Weight | Body mass index
Item
healthy male or female subjects between 18 and 65 years of age inclusive with body weight >= 50 kg and body mass index (bmi) within the range 19 to 32 kilogram/meter squared
boolean
C1708335 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0005910 (UMLS CUI [3])
C1305855 (UMLS CUI [4])
Alanine aminotransferase normal ECG | Alkaline phosphatase normal ECG | Bilirubin normal ECG
Item
alanine aminotransferase (alt) alkaline phosphatase and bilirubin <or=1.5x upper limit of normal (uln).
boolean
C0855620 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C0858306 (UMLS CUI [2,1])
C1623258 (UMLS CUI [2,2])
C0858307 (UMLS CUI [3,1])
C1623258 (UMLS CUI [3,2])
QTcF - Fridericia's Correction Formula | Bundle-Branch Block | ECG Quantity Timespan
Item
normal ecg measurements. average qt duration corrected for heart rate by fridericia's formula (qtcf) <450 millisecond or qtcf <480 msec in subjects with bundle branch block based on an average from three electrocardiograms (ecgs) obtained over a brief recording period.
boolean
C1882513 (UMLS CUI [1])
C0006384 (UMLS CUI [2])
C1623258 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0872291 (UMLS CUI [3,3])
Gender Childbearing Potential Absent | Pregnancy Absent | Childbearing Potential Contraceptive methods | Metformin | glimepiride
Item
female subjects of non-child bearing potential. females of child bearing potential are eligible to enter if they are not pregnant and willing to use protocol-specified methods of contraception to prevent pregnancy until 14 days post-last dose of metformin/glimepiride.
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0025598 (UMLS CUI [4])
C0061323 (UMLS CUI [5])
Informed Consent
Item
capable of giving written informed consent
boolean
C0021430 (UMLS CUI [1])
Substance of abuse Screen Positive | Hepatitis viral test positive | HIV Seropositivity
Item
the subject has a positive: drug/alcohol screen, hepatitis, hiv screen
boolean
C0687130 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C3495836 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Alcohol abuse
Item
abuse of alcohol
boolean
C0085762 (UMLS CUI [1])
Liver disease | Chronic liver disease | Abnormality of the liver | Biliary tract abnormality
Item
current or chronic history of liver disease, or known hepatic or biliary abnormalities
boolean
C0023895 (UMLS CUI [1])
C0341439 (UMLS CUI [2])
C4021780 (UMLS CUI [3])
C0549613 (UMLS CUI [4])
Exposure to Chemicals Investigational Quantity
Item
exposure to more than four new investigational chemical entities within 12 months prior to the first dosing day
boolean
C0332157 (UMLS CUI [1,1])
C0220806 (UMLS CUI [1,2])
C1517586 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Study Subject Participation Status | Investigational New Drugs
Item
participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Component Investigational New Drug | Drug Allergy | Hypersensitivity Participation Contraindicated
Item
sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or gsk medical monitor, contraindicates their participation
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C0013230 (UMLS CUI [2,3])
C0013182 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0679823 (UMLS CUI [4,2])
C1444657 (UMLS CUI [4,3])
Blood Donation Amount Timespan
Item
donation of more than 500 ml blood within a 56 day period
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
unwillingness or inability to follow the procedures outlined in the protocol
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Mental handicap | Legal capacity Lacking
Item
subject is mentally or legally incapacitated
boolean
C1306341 (UMLS CUI [1])
C0683673 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Urine cotinine test positive | Tobacco use | Use of Nicotine product
Item
subject having positive urinary cotinine levels indicative of use of tobacco or nicotine-containing products within 6 months prior to screening.
boolean
C1699505 (UMLS CUI [1])
C0543414 (UMLS CUI [2])
C1524063 (UMLS CUI [3,1])
C0028040 (UMLS CUI [3,2])
Consumption Red wine Discontinue Unable | Consumption Citrus aurantium Extract Discontinue Unable | Consumption Grapefruit Discontinue Unable | Consumption GRAPEFRUIT JUICE Discontinue Unable
Item
unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose
boolean
C0009830 (UMLS CUI [1,1])
C0349371 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C0009830 (UMLS CUI [2,1])
C0330922 (UMLS CUI [2,2])
C1705851 (UMLS CUI [2,3])
C1444662 (UMLS CUI [2,4])
C1299582 (UMLS CUI [2,5])
C0009830 (UMLS CUI [3,1])
C0995150 (UMLS CUI [3,2])
C1444662 (UMLS CUI [3,3])
C1299582 (UMLS CUI [3,4])
C0009830 (UMLS CUI [4,1])
C0452456 (UMLS CUI [4,2])
C1444662 (UMLS CUI [4,3])
C1299582 (UMLS CUI [4,4])
Asthma | Carbon Monoxide Positive
Item
subjects having asthma or are positive carbon monoxide (co) on admission to the unit
boolean
C0004096 (UMLS CUI [1])
C0007018 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Pharmaceutical Preparations Discontinue Unable | Non-Prescription Drugs Discontinue Unable
Item
unable to refrain from the use of prescription or non-prescription drugs within 7 days prior to first dose of study medication, unless approved by the investigator and gsk medical monitor.
boolean
C0013227 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0013231 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])