ID

32667

Beschreibung

Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State; ODM derived from: https://clinicaltrials.gov/show/NCT01002807

Link

https://clinicaltrials.gov/show/NCT01002807

Stichworte

Versionen (1)
  1. 11.11.18 11.11.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

11. November 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus (T2DM) NCT01002807

Englisch

Eligibility Type 2 Diabetes Mellitus (T2DM) NCT01002807

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women ages 18 to 45 inclusive
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations
Beschreibung

Healthy Volunteers | Medical History Normal | Physical examination normal | ECG normal | Laboratory test normal

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0205307
UMLS CUI [3]
C0855737
UMLS CUI [4]
C0522054
UMLS CUI [5]
C1096215
body mass index (bmi) of 18 to 32 kg/m2, inclusive. bmi = weight (kg)/ [height (m)]2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
wocbp who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
Beschreibung

Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1299582
any significant acute or chronic medical illness
Beschreibung

Illness Significant | Chronic disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0008679
current or recent (within 3 months) gastrointestinal disease
Beschreibung

Gastrointestinal Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0017178
any major surgery within 4 weeks of study drug administration
Beschreibung

Major surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
glucosuria at screening
Beschreibung

Glycosuria

Datentyp

boolean

Alias
UMLS CUI [1]
C0017979
abnormal liver functions tests (alt, ast or total bilirubin > 10% above uln)
Beschreibung

Liver function tests abnormal | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C0151766
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0741494
presence of edema on physical exam
Beschreibung

Edema Physical Examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013604
UMLS CUI [1,2]
C0031809
history of diabetes mellitus
Beschreibung

History of diabetes mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0455488
history of heart failure
Beschreibung

Heart failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0018801
history of renal insufficiency
Beschreibung

Renal Insufficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C1565489
history of chronic or recurrent uti (defined as 3 occurrences per year) or uti in the past 3 months
Beschreibung

Chronic urinary tract infection | Recurrent urinary tract infection | Number of occurrences per year

Datentyp

boolean

Alias
UMLS CUI [1]
C0262421
UMLS CUI [2]
C0262655
UMLS CUI [3,1]
C0449789
UMLS CUI [3,2]
C0439508
history of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
Beschreibung

Vulvovaginal mycotic infection Recurrent | Number of occurrences per year | Vulvovaginal mycotic infection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1609512
UMLS CUI [1,2]
C2945760
UMLS CUI [2,1]
C0449789
UMLS CUI [2,2]
C0439508
UMLS CUI [3]
C1609512
estimated creatinine clearance (clcr) of < 80 ml/min using the cockcroft gault formula
Beschreibung

Estimation of creatinine clearance by Cockcroft-Gault formula

Datentyp

boolean

Alias
UMLS CUI [1]
C2711451
history of allergy or intolerance to metformin or other similar agents
Beschreibung

Metformin allergy | Intolerance to Metformin | Hypersensitivity Pharmaceutical Preparations Similar | Intolerance to Pharmaceutical Preparations Similar

Datentyp

boolean

Alias
UMLS CUI [1]
C0571648
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0025598
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C2348205
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C2348205
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Ähnliche Modelle

Eligibility Type 2 Diabetes Mellitus (T2DM) NCT01002807

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women ages 18 to 45 inclusive
boolean
C0001779 (UMLS CUI [1])
Healthy Volunteers | Medical History Normal | Physical examination normal | ECG normal | Laboratory test normal
Item
healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations
boolean
C1708335 (UMLS CUI [1])
C0262926 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0855737 (UMLS CUI [3])
C0522054 (UMLS CUI [4])
C1096215 (UMLS CUI [5])
Body mass index
Item
body mass index (bmi) of 18 to 32 kg/m2, inclusive. bmi = weight (kg)/ [height (m)]2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable
Item
wocbp who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Illness Significant | Chronic disease
Item
any significant acute or chronic medical illness
boolean
C0221423 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2])
Gastrointestinal Disease
Item
current or recent (within 3 months) gastrointestinal disease
boolean
C0017178 (UMLS CUI [1])
Major surgery
Item
any major surgery within 4 weeks of study drug administration
boolean
C0679637 (UMLS CUI [1])
Glycosuria
Item
glucosuria at screening
boolean
C0017979 (UMLS CUI [1])
Liver function tests abnormal | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin
Item
abnormal liver functions tests (alt, ast or total bilirubin > 10% above uln)
boolean
C0151766 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
Edema Physical Examination
Item
presence of edema on physical exam
boolean
C0013604 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
History of diabetes mellitus
Item
history of diabetes mellitus
boolean
C0455488 (UMLS CUI [1])
Heart failure
Item
history of heart failure
boolean
C0018801 (UMLS CUI [1])
Renal Insufficiency
Item
history of renal insufficiency
boolean
C1565489 (UMLS CUI [1])
Chronic urinary tract infection | Recurrent urinary tract infection | Number of occurrences per year
Item
history of chronic or recurrent uti (defined as 3 occurrences per year) or uti in the past 3 months
boolean
C0262421 (UMLS CUI [1])
C0262655 (UMLS CUI [2])
C0449789 (UMLS CUI [3,1])
C0439508 (UMLS CUI [3,2])
Vulvovaginal mycotic infection Recurrent | Number of occurrences per year | Vulvovaginal mycotic infection
Item
history of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
boolean
C1609512 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0449789 (UMLS CUI [2,1])
C0439508 (UMLS CUI [2,2])
C1609512 (UMLS CUI [3])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
estimated creatinine clearance (clcr) of < 80 ml/min using the cockcroft gault formula
boolean
C2711451 (UMLS CUI [1])
Metformin allergy | Intolerance to Metformin | Hypersensitivity Pharmaceutical Preparations Similar | Intolerance to Pharmaceutical Preparations Similar
Item
history of allergy or intolerance to metformin or other similar agents
boolean
C0571648 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C0025598 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
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