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:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT02579356
Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects between the ages of 19 and 55 years
* Subjects who don't have congenital or chronic diseases and have no abnormal medical examination results within 3 years
* Healthy Subjects (no clinically relevant findings in any of the investigations of the pre-examination) as judged by the investigator
* Subjects who signed and dated in informed consent form indicating that the subject has decided to participate in the study after being informed of all pertinent aspects of the study
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion Criteria:
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
* Any condition possibly affecting drug absorption, distribution, metabolism, and excretion (e.g. gastrectomy)
* Twofold or more than upper limit of normal range in laboratory test for ALT or AST
* Participating in other clinical trial study within 2 month preceding the first dose of investigational product
* History of significant alcohol abuse or drug abuse within one year prior to the screening
* Whole blood donation within 2 months prior to dosing, or apheresis donation within 1 month prior to dosing
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
* Unwilling or unable to comply with the lifestyle guidelines described in this protocol
* Subjects who are inadequate for this study to participate judged by investigator
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT02579356
Study Brief:
Protocol Section:
NCT02579356