Healthy Volunteer | Age | Body Weight Percentage Ideal Body Weight
Item
a healthy volunteer between 20 and 55 years old with body weight within 20% of ideal body weight.
boolean
C1708335 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0005910 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0421272 (UMLS CUI [3,3])
Congenital Disorders Absent | Chronic disease Absent | Symptoms Absent
Item
have not any congenital or chronic diseases and medical symptom.
boolean
C0242354 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Study Subject Participation Status Appropriate | Patient interview | Vital signs | 12 lead ECG | Physical Examination | Hematologic Test | Urinalysis
Item
appropriate for the study judging from examinations(interview, vital signs, 12-lead ecg, physical examination, blood, urinalysis result on screening).
boolean
C2348568 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0683518 (UMLS CUI [2])
C0518766 (UMLS CUI [3])
C0430456 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
C0018941 (UMLS CUI [6])
C0042014 (UMLS CUI [7])
Participation Clinical Trial Complete
Item
able to participate in the entire trial.
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Informed Consent
Item
signed the informed consent form prior to the study participation.
boolean
C0021430 (UMLS CUI [1])
Pharmaceutical Preparations Inducing Enzyme metabolic function | Enzyme metabolic function Inhibitor | Barbiturates
Item
take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first ip administraion.
boolean
C0013227 (UMLS CUI [1,1])
C0205263 (UMLS CUI [1,2])
C1277048 (UMLS CUI [1,3])
C1277048 (UMLS CUI [2,1])
C1999216 (UMLS CUI [2,2])
C0004745 (UMLS CUI [3])
Acute Disease
Item
the evidence of acute disease within 28 days prior to the first ip administraion.
boolean
C0001314 (UMLS CUI [1])
Disease Influence Absorption Investigational New Drugs | Disease Influence Distribution Investigational New Drugs | Disease Influence Metabolism Investigational New Drugs | Disease Influence Excretion Investigational New Drugs | Inflammatory Bowel Diseases | Gastric ulcer | Duodenal Ulcer | Liver diseases | Gastrointestinal Surgical Procedure | Exception Appendectomy
Item
disease(ex: imflammatory intestinal disease, gastric or duodenal ulcer ,hepatic diseasehistory , gastro intestinal surgery exept for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
boolean
C0012634 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C2698777 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C0012634 (UMLS CUI [3,1])
C4054723 (UMLS CUI [3,2])
C2698779 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C0012634 (UMLS CUI [4,1])
C4054723 (UMLS CUI [4,2])
C2699704 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])
C0021390 (UMLS CUI [5])
C0038358 (UMLS CUI [6])
C0013295 (UMLS CUI [7])
C0023895 (UMLS CUI [8])
C0524722 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0003611 (UMLS CUI [10,2])
Drug Allergy | Hypersensitivity | Exception Rhinitis Mild
Item
relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication.
boolean
C0013182 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0035455 (UMLS CUI [3,2])
C2945599 (UMLS CUI [3,3])
Hypersensitivity Telmisartan | Amlodipine allergy
Item
hypersensitivity telmisartan or amlodipine.
boolean
C0020517 (UMLS CUI [1,1])
C0248719 (UMLS CUI [1,2])
C0570921 (UMLS CUI [2])
Systolic Pressure | Diastolic blood pressure
Item
sbp<90mmhg or dbp<50mmhg.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Laboratory test result abnormal | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin
Item
abnormal laboratory result(s): ast or alt > 1.25 times of upper limit / total bilirubin > 1.5 times of upper limit.
boolean
C0438215 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
Drug abuse | Caffeine Consumption cups per day | Heavy tobacco smoker Number of cigarettes per day | Alcohol consumption Regular gram per day | Alcohol consumption Recent
Item
a drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or a heavy smoker(more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first ip administration.
boolean
C0013146 (UMLS CUI [1])
C0006644 (UMLS CUI [2,1])
C0009830 (UMLS CUI [2,2])
C0560654 (UMLS CUI [2,3])
C3494625 (UMLS CUI [3,1])
C3694146 (UMLS CUI [3,2])
C0001948 (UMLS CUI [4,1])
C0205272 (UMLS CUI [4,2])
C0439417 (UMLS CUI [4,3])
C0001948 (UMLS CUI [5,1])
C0332185 (UMLS CUI [5,2])
Diet Influence Absorption Investigational New Drugs | Diet Influence Distribution Investigational New Drugs | Diet Influence Metabolism Investigational New Drugs | Diet Influence Excretion Investigational New Drugs | GRAPEFRUIT JUICE
Item
diet(especially, grapefruit juice-within 7 days prior to the first ip administraion) that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
boolean
C0012155 (UMLS CUI [1,1])
C4054723 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0012155 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C2698777 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C0012155 (UMLS CUI [3,1])
C4054723 (UMLS CUI [3,2])
C2698779 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C0012155 (UMLS CUI [4,1])
C4054723 (UMLS CUI [4,2])
C2699704 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])
C0452456 (UMLS CUI [5])
Whole blood Donation
Item
donated whole blood within 60 days prior to the first ip administraion.
boolean
C0370231 (UMLS CUI [1,1])
C0005794 (UMLS CUI [1,2])
Study Subject Participation Status | Clinical Trial
Item
participated in the other clinical trials within 90days prior to the first ip administraion.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
Pharmaceutical Preparation Recent | Pharmaceutical Preparation Affecting Clinical Trial
Item
medicine within 10 days prior to the first ip administraion? does the medication affect this trial.
boolean
C0013227 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Gender Contraceptive methods Absent
Item
a pregnant or nursing women who does not use medically acceptable birth control.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Study Subject Participation Status Appropriate
Item
appropriate for the trial judging from principal investigator.
boolean
C2348568 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])