ID

34684

Description

Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00935467

Link

https://clinicaltrials.gov/show/NCT00935467

Keywords

Versions (1)
  1. 1/23/19 1/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 23, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00935467

English

Eligibility Type 2 Diabetes Mellitus NCT00935467

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men and women ages 18 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, ecgs, and clinical laboratory determinations
Description

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

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]
C0438214
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
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 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
prior exposure to saxagliptin
Description

Exposure to Saxagliptin

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1611934
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00935467

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 | 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 Barrier Contraception Unwilling | Childbearing Potential Barrier Contraception Unable | Female Condoms | Vaginal Spermicides
Item
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 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])
Exposure to Saxagliptin
Item
prior exposure to saxagliptin
boolean
C0332157 (UMLS CUI [1,1])
C1611934 (UMLS CUI [1,2])
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