ID

37314

Description

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

Link

https://clinicaltrials.gov/show/NCT02060201

Keywords

Versions (1)
  1. 7/16/19 7/16/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 16, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT02060201

English

Eligibility Type 2 Diabetes Mellitus NCT02060201

1 forms  
Criteria
Description

Criteria

Inclusion Criteria
Description

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
Description

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

Data type

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)
Description

Body mass index

Data type

boolean

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

Age

Data type

boolean

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

Childbearing Potential Contraceptive methods

Data type

boolean

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

Exclusion Criteria

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

Illness | Chronic disease

Data type

boolean

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

Gastrointestinal Disease

Data type

boolean

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

Major surgery

Data type

boolean

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

Chronic urinary tract infection | Recurrent urinary tract infection | Gender

Data type

boolean

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

Glucose intolerance | Diabetes Mellitus

Data type

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
Description

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

Data type

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
Description

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

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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