ID

40805

Beschreibung

CKD-828(80/2.5mg) Pharmacokinetic Study; ODM derived from: https://clinicaltrials.gov/show/NCT01246193

Link

https://clinicaltrials.gov/show/NCT01246193

Stichworte

Versionen (1)
  1. 16.05.20 16.05.20 -
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See clinicaltrials.gov

Hochgeladen am

16. Mai 2020

DOI

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Eligibility Hypertension NCT01246193

Englisch

Eligibility Hypertension NCT01246193

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Healthy Volunteer | Age | Body Weight Percentage Ideal Body Weight

Datentyp

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.
Beschreibung

Congenital Disorders Absent | Chronic disease Absent | Symptoms Absent

Datentyp

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).
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548787
UMLS CUI [2]
C0683518
UMLS CUI [3]
C0518766
UMLS CUI [4]
C0430456
UMLS CUI [5]
C0031809
UMLS CUI [6]
C0018941
UMLS CUI [7]
C0042014
able to participate in the entire trial.
Beschreibung

Participation Clinical Trial Complete

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679823
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205197
signed the informed consent form prior to the study participation.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Pharmaceutical Preparations Inducing Enzyme metabolic function | Enzyme metabolic function Inhibitor | Barbiturates

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205263
UMLS CUI [1,3]
C1277048
UMLS CUI [2,1]
C1277048
UMLS CUI [2,2]
C1999216
UMLS CUI [3]
C0004745
the evidence of acute disease within 28 days prior to the first ip administraion.
Beschreibung

Acute Disease

Datentyp

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).
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C2698777
UMLS CUI [2,4]
C0013230
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C4054723
UMLS CUI [3,3]
C2698779
UMLS CUI [3,4]
C0013230
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C4054723
UMLS CUI [4,3]
C2699704
UMLS CUI [4,4]
C0013230
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.
Beschreibung

Drug Allergy | Hypersensitivity | Exception Rhinitis Mild

Datentyp

boolean

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

Hypersensitivity Telmisartan | Amlodipine allergy

Datentyp

boolean

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

Systolic Pressure | Diastolic blood pressure

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Drug abuse | Caffeine Consumption cups per day | Heavy tobacco smoker Number of cigarettes per day | Alcohol consumption Regular gram per day | Alcohol consumption Recent

Datentyp

boolean

Alias
UMLS CUI [1]
C0013146
UMLS CUI [2,1]
C0006644
UMLS CUI [2,2]
C0009830
UMLS CUI [2,3]
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]
C0439417
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).
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0012155
UMLS CUI [1,2]
C4054723
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0012155
UMLS CUI [2,2]
C4054723
UMLS CUI [2,3]
C2698777
UMLS CUI [2,4]
C0013230
UMLS CUI [3,1]
C0012155
UMLS CUI [3,2]
C4054723
UMLS CUI [3,3]
C2698779
UMLS CUI [3,4]
C0013230
UMLS CUI [4,1]
C0012155
UMLS CUI [4,2]
C4054723
UMLS CUI [4,3]
C2699704
UMLS CUI [4,4]
C0013230
UMLS CUI [5]
C0452456
donated whole blood within 60 days prior to the first ip administraion.
Beschreibung

Whole blood Donation

Datentyp

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.
Beschreibung

Study Subject Participation Status | Clinical Trial

Datentyp

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.
Beschreibung

Pharmaceutical Preparation Recent | Pharmaceutical Preparation Affecting Clinical Trial

Datentyp

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
a pregnant or nursing women who does not use medically acceptable birth control.
Beschreibung

Pregnancy | Breast Feeding | Gender Contraceptive methods Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
appropriate for the trial judging from principal investigator.
Beschreibung

Study Subject Participation Status Appropriate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548787
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Ähnliche Modelle

Eligibility Hypertension NCT01246193

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 | 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])
Item Group
C0680251 (UMLS CUI)
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])
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