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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT02540460
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male between 20 and 45 years of age at the time of screening
2. Subjects with body mass index (BMI) between 20 kg/m2 and 27 kg/m2 at the time of screening
3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days after study completion
4. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements.
Exclusion Criteria:
1. History of liver, kidney, alimentary, respiratory, musculoskeletal, endocrine, neuropsychiatric, hemato-oncologic, cardiovascular problem(s)
2. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 6 months possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)
3. History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics
4. History of drug abuse or positive result at urine drug screening
5. AST, ALT, r-GT, bilirubin(total) values over than 1.5 times of ULN
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT02540460
Study Brief:
Protocol Section:
NCT02540460