ID

39029

Description

Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers; ODM derived from: https://clinicaltrials.gov/show/NCT01725672

Link

https://clinicaltrials.gov/show/NCT01725672

Keywords

Versions (1)
  1. 11/22/19 11/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 22, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT01725672

English

Eligibility Diabetes Mellitus, Type 2 NCT01725672

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
Description

Healthy Volunteers | Age | Body Weight | Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0005910
UMLS CUI [4]
C1305855
alanine aminotransferase (alt) alkaline phosphatase and bilirubin <or=1.5x upper limit of normal (uln).
Description

Alanine aminotransferase normal ECG | Alkaline phosphatase normal ECG | Bilirubin normal ECG

Data type

boolean

Alias
UMLS CUI [1,1]
C0855620
UMLS CUI [1,2]
C1623258
UMLS CUI [2,1]
C0858306
UMLS CUI [2,2]
C1623258
UMLS CUI [3,1]
C0858307
UMLS CUI [3,2]
C1623258
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.
Description

QTcF - Fridericia's Correction Formula | Bundle-Branch Block | ECG Quantity Timespan

Data type

boolean

Alias
UMLS CUI [1]
C1882513
UMLS CUI [2]
C0006384
UMLS CUI [3,1]
C1623258
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0872291
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.
Description

Gender Childbearing Potential Absent | Pregnancy Absent | Childbearing Potential Contraceptive methods | Metformin | glimepiride

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0025598
UMLS CUI [5]
C0061323
capable of giving written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the subject has a positive: drug/alcohol screen, hepatitis, hiv screen
Description

Substance of abuse Screen Positive | Hepatitis viral test positive | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0687130
UMLS CUI [1,2]
C0220908
UMLS CUI [1,3]
C1514241
UMLS CUI [2]
C3495836
UMLS CUI [3]
C0019699
abuse of alcohol
Description

Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C0085762
current or chronic history of liver disease, or known hepatic or biliary abnormalities
Description

Liver disease | Chronic liver disease | Abnormality of the liver | Biliary tract abnormality

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0341439
UMLS CUI [3]
C4021780
UMLS CUI [4]
C0549613
exposure to more than four new investigational chemical entities within 12 months prior to the first dosing day
Description

Exposure to Chemicals Investigational Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0220806
UMLS CUI [1,3]
C1517586
UMLS CUI [1,4]
C1265611
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)
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
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
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Component Investigational New Drug | Drug Allergy | Hypersensitivity Participation Contraindicated

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C0013230
UMLS CUI [3]
C0013182
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0679823
UMLS CUI [4,3]
C1444657
donation of more than 500 ml blood within a 56 day period
Description

Blood Donation Amount Timespan

Data type

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0872291
pregnant or lactating females
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
unwillingness or inability to follow the procedures outlined in the protocol
Description

Protocol Compliance Unwilling | Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
subject is mentally or legally incapacitated
Description

Mental handicap | Legal capacity Lacking

Data type

boolean

Alias
UMLS CUI [1]
C1306341
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0332268
subject having positive urinary cotinine levels indicative of use of tobacco or nicotine-containing products within 6 months prior to screening.
Description

Urine cotinine test positive | Tobacco use | Use of Nicotine product

Data type

boolean

Alias
UMLS CUI [1]
C1699505
UMLS CUI [2]
C0543414
UMLS CUI [3,1]
C1524063
UMLS CUI [3,2]
C0028040
unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose
Description

Consumption Red wine Discontinue Unable | Consumption Citrus aurantium Extract Discontinue Unable | Consumption Grapefruit Discontinue Unable | Consumption GRAPEFRUIT JUICE Discontinue Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C0349371
UMLS CUI [1,3]
C1444662
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C0009830
UMLS CUI [2,2]
C0330922
UMLS CUI [2,3]
C1705851
UMLS CUI [2,4]
C1444662
UMLS CUI [2,5]
C1299582
UMLS CUI [3,1]
C0009830
UMLS CUI [3,2]
C0995150
UMLS CUI [3,3]
C1444662
UMLS CUI [3,4]
C1299582
UMLS CUI [4,1]
C0009830
UMLS CUI [4,2]
C0452456
UMLS CUI [4,3]
C1444662
UMLS CUI [4,4]
C1299582
subjects having asthma or are positive carbon monoxide (co) on admission to the unit
Description

Asthma | Carbon Monoxide Positive

Data type

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2,1]
C0007018
UMLS CUI [2,2]
C1514241
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.
Description

Pharmaceutical Preparations Discontinue Unable | Non-Prescription Drugs Discontinue Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C1299582
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01725672

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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