Information:
Fel:
ID
34688
Beskrivning
Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects; ODM derived from: https://clinicaltrials.gov/show/NCT01068730
Länk
https://clinicaltrials.gov/show/NCT01068730
Nyckelord
Versioner (1)
- 2019-01-23 2019-01-23 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
23 januari 2019
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT01068730
Eligibility Type 2 Diabetes Mellitus NCT01068730
- StudyEvent: Eligibility
Similar models
Eligibility Type 2 Diabetes Mellitus NCT01068730
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Age
Item
men and women ages 18 to 55 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, 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])
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])
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])
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])
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 Metformin
Item
prior exposure to metformin within 3 months of study drug administration
boolean
C0332157 (UMLS CUI [1,1])
C0025598 (UMLS CUI [1,2])
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])