Informações:
Falhas:
ID
34684
Descrição
Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT00935467
Link
https://clinicaltrials.gov/show/NCT00935467
Palavras-chave
Versões (1)
- 23/01/2019 23/01/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
23 de janeiro de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00935467
Eligibility Type 2 Diabetes Mellitus NCT00935467
- StudyEvent: Eligibility
Similar models
Eligibility Type 2 Diabetes Mellitus NCT00935467
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
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])
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])
C1611934 (UMLS CUI [1,2])