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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT03896594
Eligibility Criteria:
Inclusion Criteria:
* A healthy adult male aged 20 years or older and 45 years old at the time of the screening test
* Those who weigh more than 55kg but weigh less than ± 20% of ideal body weight
* Proper contraception during the clinical trial period
* After hearing the detailed explanation of the clinical trial, those who decide to participate voluntarily and write agreement
Exclusion Criteria:
* Clinically significant, a person with a history of neurological, psychiatric, malignant, cardiovascular, respiratory, kidney, endocrine, hematologic, digestive or central disease
* a person with a history of gastrointestinal disorders that may affect the absorption of pharmaceuticals for clinical trials (Crohn's disease, ulcers, etc.) or gastrointestinal surgery (except for simple cecal surgery or hernia surgery)
* a person with a history of hypersensitivity or clinically significant hypersensitivity to the clinical trial drug or additives
* a person judged to be inappropriate for the subject by health screening (history of disease, physical examination, vital signs, electrocardiogram, laboratory test, etc.)
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT03896594
Study Brief:
Protocol Section:
NCT03896594