Eligibility Diabetes Mellitus, Type 2 NCT01537497

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
Beschrijving

ID.1

Datatype

boolean

healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests. in addition, subjects must have normal pulmonary function tests and normal ocular findings.
Beschrijving

ID.2

Datatype

boolean

women must be of non-childbearing potential.
Beschrijving

ID.3

Datatype

boolean

body mass index (bmi) of 19.5 35.5 kg/m2, and a total body weight of > 50 kg (110 lbs).
Beschrijving

ID.4

Datatype

boolean

Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and seasonal allergies at time of dosing).
Beschrijving

ID.5

Datatype

boolean

evidence or history of any chronic ongoing or current pulmonary disease.
Beschrijving

ID.6

Datatype

boolean

history of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of screening or positive cotinine test at screening or day -7.
Beschrijving

ID.7

Datatype

boolean

active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
Beschrijving

ID.8

Datatype

boolean

Similar models

Eligibility Diabetes Mellitus, Type 2 NCT01537497

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
boolean
ID.2
Item
healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests. in addition, subjects must have normal pulmonary function tests and normal ocular findings.
boolean
ID.3
Item
women must be of non-childbearing potential.
boolean
ID.4
Item
body mass index (bmi) of 19.5 35.5 kg/m2, and a total body weight of > 50 kg (110 lbs).
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and seasonal allergies at time of dosing).
boolean
ID.6
Item
evidence or history of any chronic ongoing or current pulmonary disease.
boolean
ID.7
Item
history of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of screening or positive cotinine test at screening or day -7.
boolean
ID.8
Item
active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
boolean