ID

20751

Beschrijving

Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT01490658

Link

https://clinicaltrials.gov/show/NCT01490658

Trefwoorden

Versies (2)
  1. 14-03-17 14-03-17 -
  2. 15-03-17 15-03-17 -
Geüploaded op

14 maart 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Eligibility Diabetes NCT01490658

Engels

Eligibility Diabetes NCT01490658

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01490658
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male and female volunteers (female not pregnant, lactating or breastfeeding)
Beschrijving

Healthy Volunteers | Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
bmi (body mass index) between 19-29 kg/m^2, both inclusive
Beschrijving

Body mass index | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0079399
fasting plasma glucose from 70-115 mg/dl
Beschrijving

Plasma fasting glucose measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0583513
subject is judged to be in good health on the basis of their medical history, physical examination, ecg (electrocardiogram), and routine laboratory data
Beschrijving

Study Subject Good health | Medical History | Physical Examination | Electrocardiography | Laboratory test finding

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C3813622
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C1623258
UMLS CUI [5]
C0587081
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any clinically significant disease history, in the opinion of the investigator, of systemic or organ disease
Beschrijving

Systemic disease | Disease body organ

Datatype

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1280836
clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening
Beschrijving

Abnormality Physical Examination | Laboratory test result abnormal

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0031809
UMLS CUI [2]
C0438215
positive results on screening for hepatitis b surface antigen, hepatitis c antibody and hiv (human immunodeficiency virus) antibody
Beschrijving

Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive

Datatype

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0281863
UMLS CUI [3]
C0920548
positive results on the drug abuse/alcohol screen
Beschrijving

Drug screen positive | Blood alcohol test positive

Datatype

boolean

Alias
UMLS CUI [1]
C0743295
UMLS CUI [2]
C0948726
any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens, other than contraceptives, that cannot be stopped at least 1 week prior to visit 2 (trial product dose administration) and for the duration of the study
Beschrijving

Pharmaceutical Preparations Regular | Non-Prescription Drugs Regular | Megavitamin Therapy | Herbal supplement | Contraceptive Agents To be stopped

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C0205272
UMLS CUI [3]
C0029340
UMLS CUI [4]
C1504473
UMLS CUI [5,1]
C0009871
UMLS CUI [5,2]
C1272691
subject is currently a smoker (more than one cigarette per day or equivalent)
Beschrijving

Tobacco use Number of cigarettes per day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
use of grapefruit or grapefruit juice within 7 days of trial product dose administration
Beschrijving

Grapefruit | GRAPEFRUIT JUICE

Datatype

boolean

Alias
UMLS CUI [1]
C0995150
UMLS CUI [2]
C0452456
blood donation, surgery or trauma with significant blood loss (500 ml) within the last 2 months prior to dosing
Beschrijving

Blood Donation | Operative Surgical Procedure Blood Loss | Trauma Blood Loss

Datatype

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C3163616
UMLS CUI [3,1]
C3714660
UMLS CUI [3,2]
C3163616
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Similar models

Eligibility Diabetes NCT01490658

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Diabetes NCT01490658
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Pregnancy | Breast Feeding
Item
healthy male and female volunteers (female not pregnant, lactating or breastfeeding)
boolean
C1708335 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Body mass index | Gender
Item
bmi (body mass index) between 19-29 kg/m^2, both inclusive
boolean
C1305855 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Plasma fasting glucose measurement
Item
fasting plasma glucose from 70-115 mg/dl
boolean
C0583513 (UMLS CUI [1])
Study Subject Good health | Medical History | Physical Examination | Electrocardiography | Laboratory test finding
Item
subject is judged to be in good health on the basis of their medical history, physical examination, ecg (electrocardiogram), and routine laboratory data
boolean
C0681850 (UMLS CUI [1,1])
C3813622 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C1623258 (UMLS CUI [4])
C0587081 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Systemic disease | Disease body organ
Item
any clinically significant disease history, in the opinion of the investigator, of systemic or organ disease
boolean
C0442893 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1280836 (UMLS CUI [2,2])
Abnormality Physical Examination | Laboratory test result abnormal
Item
clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening
boolean
C1704258 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2])
Hepatitis B surface antigen positive | Hepatitis C antibody positive | HIV antibody positive
Item
positive results on screening for hepatitis b surface antigen, hepatitis c antibody and hiv (human immunodeficiency virus) antibody
boolean
C0149709 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
C0920548 (UMLS CUI [3])
Drug screen positive | Blood alcohol test positive
Item
positive results on the drug abuse/alcohol screen
boolean
C0743295 (UMLS CUI [1])
C0948726 (UMLS CUI [2])
Pharmaceutical Preparations Regular | Non-Prescription Drugs Regular | Megavitamin Therapy | Herbal supplement | Contraceptive Agents To be stopped
Item
any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens, other than contraceptives, that cannot be stopped at least 1 week prior to visit 2 (trial product dose administration) and for the duration of the study
boolean
C0013227 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0013231 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0029340 (UMLS CUI [3])
C1504473 (UMLS CUI [4])
C0009871 (UMLS CUI [5,1])
C1272691 (UMLS CUI [5,2])
Tobacco use Number of cigarettes per day
Item
subject is currently a smoker (more than one cigarette per day or equivalent)
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Grapefruit | GRAPEFRUIT JUICE
Item
use of grapefruit or grapefruit juice within 7 days of trial product dose administration
boolean
C0995150 (UMLS CUI [1])
C0452456 (UMLS CUI [2])
Blood Donation | Operative Surgical Procedure Blood Loss | Trauma Blood Loss
Item
blood donation, surgery or trauma with significant blood loss (500 ml) within the last 2 months prior to dosing
boolean
C0005794 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C3163616 (UMLS CUI [2,2])
C3714660 (UMLS CUI [3,1])
C3163616 (UMLS CUI [3,2])
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