Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT00426920
Eligibility Criteria:
Inclusion Criteria:
* male
* non smoking for at least 12 months
* BMI equal to or less than 28
* no clinically significant abnormalities
* FVC and FEV1 equal to or more than 80%
* willing to participate and to sign informed consent form
Exclusion Criteria:
* positive results for insulin antibodies at screening
* history of substance abuse or dependency within last 5 years
* positive screening test for substance abuse
* positive blood test for HIV, hepatitis B or hepatitis C antibody
* fasting blood glucose of more than 126mg/dl
* any existing medical conditions which might interfere with absoprtion, distribution, metabolism or excretion of study medication
* history of bronchospastic disease(asthma), tachycardia, migraine headache, hypoglycemic episodes, jaundice, liver diseases, arterial hemorrhaging, severe hypertension or hypotension, cardiac abnormality, renal disease, allergies, unresolved psychiatric illness, drug-induced myopathy or any other clinically significant abnormality
* has received investigational medications within 21 days prior to receiving the first dose of study medication
* has taken or used any prescription medications within 21 days prior to receiving the first dose of study medication
* has taken or used any OTC medications,vitamins or herbal and/or nutritional supplements within 10 days days prior to receiving the first dose of study medication
* health that may be adversely affected by procedures or medications used in the study
* unwillingness or inability to understand or to follow required study restrictions and procedures
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00426920
Study Brief:
Protocol Section:
NCT00426920