ID

37314

Beskrivning

Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC); ODM derived from: https://clinicaltrials.gov/show/NCT02060201

Länk

https://clinicaltrials.gov/show/NCT02060201

Nyckelord

Versioner (1)
  1. 2019-07-16 2019-07-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 juli 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02060201

Engelsk

Eligibility Type 2 Diabetes Mellitus NCT02060201

1 Formulär  
Criteria
Beskrivning

Criteria

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 (pe), vital signs, 12-lead ecg, and clinical laboratory determinations
Beskrivning

Healthy Volunteers Medical History | Healthy Volunteers Physical Examination | Healthy Volunteers Vital signs | Healthy Volunteers 12 lead ECG | Healthy Volunteers Laboratory Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1708335
UMLS CUI [2,2]
C0031809
UMLS CUI [3,1]
C1708335
UMLS CUI [3,2]
C0518766
UMLS CUI [4,1]
C1708335
UMLS CUI [4,2]
C0430456
UMLS CUI [5,1]
C1708335
UMLS CUI [5,2]
C0022885
body mass index (bmi) of 18.5 to 30 kg/m(2)
Beskrivning

Body mass index

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
men and women, ages 18 to 50 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
women of childbearing potential must use acceptable methods of highly effective birth control
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any significant acute or chronic medical illness
Beskrivning

Illness | Chronic disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2]
C0008679
current or recent gastrointestinal disease
Beskrivning

Gastrointestinal Disease

Datatyp

boolean

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

Major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
history of chronic or recurrent urinary tract infection for females
Beskrivning

Chronic urinary tract infection | Recurrent urinary tract infection | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0262421
UMLS CUI [2]
C0262655
UMLS CUI [3]
C0079399
history of glucose intolerance or diabetes mellitus
Beskrivning

Glucose intolerance | Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1]
C0271650
UMLS CUI [2]
C0011849
history of allergies or adverse reactions to dipeptidyl peptidase-iv (dpp4) or sodium-glucose cotransporter (sglt) inhibitors
Beskrivning

Hypersensitivity Dipeptidyl-Peptidase IV Inhibitors | Adverse reactions Dipeptidyl-Peptidase IV Inhibitors | Hypersensitivity Sodium-Glucose Transporter Inhibitors | Adverse reactions Sodium-Glucose Transporter Inhibitors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1827106
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C1827106
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C3665045
UMLS CUI [4,1]
C0559546
UMLS CUI [4,2]
C3665045
prior exposure to saxagliptin or dapagliflozin or related drugs
Beskrivning

Exposure to Saxagliptin | Exposure to Dapagliflozin | Exposure to Pharmaceutical Preparations Related

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1611934
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C2353951
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0439849
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT02060201

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers Medical History | Healthy Volunteers Physical Examination | Healthy Volunteers Vital signs | Healthy Volunteers 12 lead ECG | Healthy Volunteers Laboratory Procedures
Item
healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination (pe), vital signs, 12-lead ecg, and clinical laboratory determinations
boolean
C1708335 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1708335 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C1708335 (UMLS CUI [3,1])
C0518766 (UMLS CUI [3,2])
C1708335 (UMLS CUI [4,1])
C0430456 (UMLS CUI [4,2])
C1708335 (UMLS CUI [5,1])
C0022885 (UMLS CUI [5,2])
Body mass index
Item
body mass index (bmi) of 18.5 to 30 kg/m(2)
boolean
C1305855 (UMLS CUI [1])
Age
Item
men and women, ages 18 to 50 years
boolean
C0001779 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential must use acceptable methods of highly effective birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Illness | Chronic disease
Item
any significant acute or chronic medical illness
boolean
C0221423 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
Gastrointestinal Disease
Item
current or recent 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])
Chronic urinary tract infection | Recurrent urinary tract infection | Gender
Item
history of chronic or recurrent urinary tract infection for females
boolean
C0262421 (UMLS CUI [1])
C0262655 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Glucose intolerance | Diabetes Mellitus
Item
history of glucose intolerance or diabetes mellitus
boolean
C0271650 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
Hypersensitivity Dipeptidyl-Peptidase IV Inhibitors | Adverse reactions Dipeptidyl-Peptidase IV Inhibitors | Hypersensitivity Sodium-Glucose Transporter Inhibitors | Adverse reactions Sodium-Glucose Transporter Inhibitors
Item
history of allergies or adverse reactions to dipeptidyl peptidase-iv (dpp4) or sodium-glucose cotransporter (sglt) inhibitors
boolean
C0020517 (UMLS CUI [1,1])
C1827106 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C1827106 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C3665045 (UMLS CUI [3,2])
C0559546 (UMLS CUI [4,1])
C3665045 (UMLS CUI [4,2])
Exposure to Saxagliptin | Exposure to Dapagliflozin | Exposure to Pharmaceutical Preparations Related
Item
prior exposure to saxagliptin or dapagliflozin or related drugs
boolean
C0332157 (UMLS CUI [1,1])
C1611934 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C2353951 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
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