ID

32909

Description

Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B); ODM derived from: https://clinicaltrials.gov/show/NCT00897390

Link

https://clinicaltrials.gov/show/NCT00897390

Keywords

Versions (1)
  1. 11/19/18 11/19/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 19, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00897390

English

Eligibility Type 2 Diabetes Mellitus NCT00897390

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women ages 19 to 45 inclusive
Description

Age

Data type

boolean

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

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

Data type

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
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of child-bearing potential (wocbp) who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
Description

Childbearing Potential Barrier Contraception Unwilling | Childbearing Potential Barrier Contraception Unable | Female Condoms | Vaginal Spermicides

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0004764
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0004764
UMLS CUI [2,3]
C1299582
UMLS CUI [3]
C0221829
UMLS CUI [4]
C0087145
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 (within 3 months) 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 allergy to dipeptidyl peptidase 4 (dpp4) inhibitor or related compounds
Description

Hypersensitivity Dipeptidyl-Peptidase IV Inhibitors | Hypersensitivity Compound Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1827106
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C0439849
history of allergy or intolerance to metformin or other similar acting agents
Description

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

Data type

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
prior exposure to saxagliptin
Description

Exposure to Saxagliptin

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1611934
prior exposure to metformin within 3 months of study drug administration
Description

Exposure to Metformin

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0025598
estimated creatinine clearance (clcr) of < 80ml/min using the cockcroft gault formula
Description

Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C2711451
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00897390

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
men and women ages 19 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, electrocardiograms (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 Barrier Contraception Unwilling | Childbearing Potential Barrier Contraception Unable | Female Condoms | Vaginal Spermicides
Item
women of child-bearing potential (wocbp) who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) 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])
C0004764 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0004764 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0221829 (UMLS CUI [3])
C0087145 (UMLS CUI [4])
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 (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])
Hypersensitivity Dipeptidyl-Peptidase IV Inhibitors | Hypersensitivity Compound Related
Item
history of allergy to dipeptidyl peptidase 4 (dpp4) inhibitor or related compounds
boolean
C0020517 (UMLS CUI [1,1])
C1827106 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
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 acting 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])
Exposure to Saxagliptin
Item
prior exposure to saxagliptin
boolean
C0332157 (UMLS CUI [1,1])
C1611934 (UMLS CUI [1,2])
Exposure to Metformin
Item
prior exposure to metformin within 3 months of study drug administration
boolean
C0332157 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
estimated creatinine clearance (clcr) of < 80ml/min using the cockcroft gault formula
boolean
C2711451 (UMLS CUI [1])
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