ID

32865

Beskrivning

Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00842556

Länk

https://clinicaltrials.gov/show/NCT00842556

Nyckelord

Versioner (1)
  1. 2018-11-17 2018-11-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 november 2018

DOI

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Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00842556

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT00842556

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations
Beskrivning

Healthy Volunteers | Medical History Normal | Physical examination normal | ECG normal | Normal Laboratory Test Result

Datatyp

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]
C0438214
body mass index (bmi) of 18 to 32 kg/m2, inclusive bmi = weight (kg)/[height(m)]2
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beskrivning

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 12 weeks after the last dose of investigational product
Beskrivning

Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable

Datatyp

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
abnormal liver functions tests (alt, ast or total bilirubin > 10% above uln)
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0151766
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0741494
history of chronic or recurrent uti (defined as 3 occurrences per year) or uti in the past 3 months
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0262421
UMLS CUI [2,1]
C0262655
UMLS CUI [2,2]
C0449789
UMLS CUI [2,3]
C0439508
UMLS CUI [3]
C0042029
history of allergy to sglt@ inhibitors, dpp$ inhibitors or sulfonylurea or related compounds
Beskrivning

Hypersensitivity SGLT Inhibitors | Hypersensitivity Dipeptidyl-Peptidase IV Inhibitors | Hypersensitivity Sulfonylurea | Hypersensitivity Compound Related

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3665045
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1827106
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0038766
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C1706082
UMLS CUI [4,3]
C0439849
prior exposure to dapagliflozin, sitagliptin and glimepiride within 3 months of day-1
Beskrivning

Exposure to Dapagliflozin | Exposure to Sitagliptin | Exposure to Glimepiride

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C2353951
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C1565750
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0061323
history of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1609512
UMLS CUI [1,2]
C2945760
UMLS CUI [1,3]
C0449789
UMLS CUI [1,4]
C0439508
UMLS CUI [2]
C1609512
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00842556

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Medical History Normal | Physical examination normal | ECG normal | Normal Laboratory Test Result
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])
C0438214 (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 12 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])
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])
Chronic urinary tract infection | Recurrent urinary tract infection Number of occurrences per year | Urinary tract infection
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 [2,1])
C0449789 (UMLS CUI [2,2])
C0439508 (UMLS CUI [2,3])
C0042029 (UMLS CUI [3])
Hypersensitivity SGLT Inhibitors | Hypersensitivity Dipeptidyl-Peptidase IV Inhibitors | Hypersensitivity Sulfonylurea | Hypersensitivity Compound Related
Item
history of allergy to sglt@ inhibitors, dpp$ inhibitors or sulfonylurea or related compounds
boolean
C0020517 (UMLS CUI [1,1])
C3665045 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1827106 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0038766 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C1706082 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
Exposure to Dapagliflozin | Exposure to Sitagliptin | Exposure to Glimepiride
Item
prior exposure to dapagliflozin, sitagliptin and glimepiride within 3 months of day-1
boolean
C0332157 (UMLS CUI [1,1])
C2353951 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C1565750 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0061323 (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 [1,3])
C0439508 (UMLS CUI [1,4])
C1609512 (UMLS CUI [2])
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