ID

39984

Descripción

CKD-828 (40/5mg) Pharmacokinetic Study; ODM derived from: https://clinicaltrials.gov/show/NCT01340131

Link

https://clinicaltrials.gov/show/NCT01340131

Palabras clave

Versiones (1)
  1. 8/3/20 8/3/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

8 de marzo de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hypertension NCT01340131

Inglés

Eligibility Hypertension NCT01340131

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
a healthy volunteer between 20 and 55 years old with body weight within 20% of ideal body weight.
Descripción

Healthy Volunteer | Age | Body Weight Percentage Ideal Body Weight

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0001779
UMLS CUI [3,1]
C0005910
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C0421272
have not any congenital or chronic diseases and medical symptom.
Descripción

Congenital Disorders Absent | Chronic disease Absent | Symptoms Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0242354
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0332197
appropriate for the study judging from examinations(interview, vital signs, 12-lead ecg, physical examination, blood, urinalysis result on screening).
Descripción

Study Subject Participation Status Appropriate Patient interview | Study Subject Participation Status Appropriate Vital signs | Study Subject Participation Status Appropriate 12 lead ECG | Study Subject Participation Status Appropriate Physical Examination | Study Subject Participation Status Appropriate Hematologic Tests | Study Subject Participation Status Appropriate Urinalysis results

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0683518
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C0518766
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C0430456
UMLS CUI [4,1]
C2348568
UMLS CUI [4,2]
C1548787
UMLS CUI [4,3]
C0031809
UMLS CUI [5,1]
C2348568
UMLS CUI [5,2]
C1548787
UMLS CUI [5,3]
C0018941
UMLS CUI [6,1]
C2348568
UMLS CUI [6,2]
C1548787
UMLS CUI [6,3]
C2097148
able to participate in the entire trial.
Descripción

Participation Clinical Trial Entire

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0439751
signed the informed consent form prior to the study participation.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first ip administraion.
Descripción

Enzyme Inducers Metabolic | Enzyme Inhibitors Metabolic | Barbiturates

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3819045
UMLS CUI [1,2]
C0311400
UMLS CUI [2,1]
C0014432
UMLS CUI [2,2]
C0311400
UMLS CUI [3]
C0004745
the evidence of acute disease within 28 days prior to the first ip administraion.
Descripción

Acute Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001314
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).
Descripción

Disease Influence Drug absorption | Disease Influence Drug distribution | Disease Influence Drug metabolism | Disease Influence Drug elimination | Inflammatory Bowel Disease | Gastric ulcer | Duodenal Ulcer | Liver diseases | Gastrointestinal Surgical Procedure | Exception Appendectomy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C0699903
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C4054723
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C4054723
UMLS CUI [4,3]
C0683141
UMLS CUI [5]
C0021390
UMLS CUI [6]
C0038358
UMLS CUI [7]
C0013295
UMLS CUI [8]
C0023895
UMLS CUI [9]
C0524722
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0003611
relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication.
Descripción

Drug Allergy | Hypersensitivity Clinical Significance | Exception Rhinitis Mild

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2826293
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0035455
UMLS CUI [3,3]
C2945599
hypersensitivity telmisartan or amlodipine.
Descripción

Hypersensitivity Telmisartan | Amlodipine allergy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0248719
UMLS CUI [2]
C0570921
sbp<90mmhg or dbp<50mmhg.
Descripción

Systolic Pressure | Diastolic blood pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
abnormal laboratory result(s): ast or alt > 1.25 times of upper limit / total bilirubin > 1.5 times of upper limit.
Descripción

Laboratory test result abnormal | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated total bilirubin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
UMLS CUI [4]
C0741494
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.
Descripción

Drug abuse | Excessive caffeine intake cups/day | Heavy tobacco smoker Number of cigarettes per day | Alcohol consumption Regular U/day | Alcohol consumption Recent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2,1]
C3714418
UMLS CUI [2,2]
C0560654
UMLS CUI [3,1]
C3494625
UMLS CUI [3,2]
C3694146
UMLS CUI [4,1]
C0001948
UMLS CUI [4,2]
C0205272
UMLS CUI [4,3]
C0456683
UMLS CUI [5,1]
C0001948
UMLS CUI [5,2]
C0332185
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).
Descripción

Diet Influence Drug absorption | Diet Influence Drug distribution | Diet Influence Drug metabolism | Diet Influence Drug elimination | GRAPEFRUIT JUICE Recent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012155
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0678745
UMLS CUI [2,1]
C0012155
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C0699903
UMLS CUI [3,1]
C0012155
UMLS CUI [3,2]
C4054723
UMLS CUI [3,3]
C0683140
UMLS CUI [4,1]
C0012155
UMLS CUI [4,2]
C4054723
UMLS CUI [4,3]
C0683141
UMLS CUI [5,1]
C0452456
UMLS CUI [5,2]
C0332185
donated whole blood within 60 days prior to the first ip administraion.
Descripción

Whole blood Donation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0370231
UMLS CUI [1,2]
C0005794
participated in the other clinical trials within 90days prior to the first ip administraion.
Descripción

Study Subject Participation Status | Clinical Trial

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
medicine within 10 days prior to the first ip administraion? does the medication affect this trial.
Descripción

Pharmaceutical Preparations Recent | Pharmaceutical Preparations Affecting Clinical Trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0008976
appropriate for the trial judging from principal investigator.
Descripción

Study Subject Participation Status Appropriate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548787
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Similar models

Eligibility Hypertension NCT01340131

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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 | Study Subject Participation Status Appropriate Vital signs | Study Subject Participation Status Appropriate 12 lead ECG | Study Subject Participation Status Appropriate Physical Examination | Study Subject Participation Status Appropriate Hematologic Tests | Study Subject Participation Status Appropriate Urinalysis results
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 [1,3])
C2348568 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C0518766 (UMLS CUI [2,3])
C2348568 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C0430456 (UMLS CUI [3,3])
C2348568 (UMLS CUI [4,1])
C1548787 (UMLS CUI [4,2])
C0031809 (UMLS CUI [4,3])
C2348568 (UMLS CUI [5,1])
C1548787 (UMLS CUI [5,2])
C0018941 (UMLS CUI [5,3])
C2348568 (UMLS CUI [6,1])
C1548787 (UMLS CUI [6,2])
C2097148 (UMLS CUI [6,3])
Participation Clinical Trial Entire
Item
able to participate in the entire trial.
boolean
C0679823 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0439751 (UMLS CUI [1,3])
Informed Consent
Item
signed the informed consent form prior to the study participation.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Enzyme Inducers Metabolic | Enzyme Inhibitors Metabolic | Barbiturates
Item
take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first ip administraion.
boolean
C3819045 (UMLS CUI [1,1])
C0311400 (UMLS CUI [1,2])
C0014432 (UMLS CUI [2,1])
C0311400 (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 Drug absorption | Disease Influence Drug distribution | Disease Influence Drug metabolism | Disease Influence Drug elimination | Inflammatory Bowel Disease | 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])
C0678745 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0699903 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C4054723 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C4054723 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
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 Clinical Significance | 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 [2,1])
C2826293 (UMLS CUI [2,2])
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 | Excessive caffeine intake cups/day | Heavy tobacco smoker Number of cigarettes per day | Alcohol consumption Regular U/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])
C3714418 (UMLS CUI [2,1])
C0560654 (UMLS CUI [2,2])
C3494625 (UMLS CUI [3,1])
C3694146 (UMLS CUI [3,2])
C0001948 (UMLS CUI [4,1])
C0205272 (UMLS CUI [4,2])
C0456683 (UMLS CUI [4,3])
C0001948 (UMLS CUI [5,1])
C0332185 (UMLS CUI [5,2])
Diet Influence Drug absorption | Diet Influence Drug distribution | Diet Influence Drug metabolism | Diet Influence Drug elimination | GRAPEFRUIT JUICE Recent
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])
C0678745 (UMLS CUI [1,3])
C0012155 (UMLS CUI [2,1])
C4054723 (UMLS CUI [2,2])
C0699903 (UMLS CUI [2,3])
C0012155 (UMLS CUI [3,1])
C4054723 (UMLS CUI [3,2])
C0683140 (UMLS CUI [3,3])
C0012155 (UMLS CUI [4,1])
C4054723 (UMLS CUI [4,2])
C0683141 (UMLS CUI [4,3])
C0452456 (UMLS CUI [5,1])
C0332185 (UMLS CUI [5,2])
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 Preparations Recent | Pharmaceutical Preparations 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])
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])
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