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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT02267902
Eligibility Criteria:
Inclusion Criteria:
* Healthy males
* Age 18 to 55
* BMI 18.0 to 30.0 kg/㎡
Exclusion Criteria:
* History of any drug or alcohol abuse in the past 2years
* Regular alcohol consumption nin males \>21 units per week
* Current smokers and those who have smoked within the last 12months
* Radiation Exposure
* Positive drugs of abuse test result
* Positive HBsAg, HCV Ab, HIV results
* Serious adverse reaction or hypersensitivity to any drug of the formulation excipients
* Clinically significant allergy
* Donation of loss of blood within the previous 3 months
* Taking any prescribed or OTC drug or herbal remedies in the 14days before IMP administration
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02267902
Study Brief:
Protocol Section:
NCT02267902