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 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT01766167
Eligibility Criteria:
Inclusion Criteria:
* Korean healthy male volunteers aged 20 to 55 years
Exclusion Criteria:
* Subjects with a BMI of \<18.5 or \>25.0, or body weight of \<50kg at prior examination
* Subjects who have had surgery that is known to affect gastrointestinal absorption of drugs (except for appendectomy and hernia surgery)
* Subjects who have had any evidence of cardiac disease at prior examination or who have a previous history of cardiac disease
* Subjects who are positive for HBs antigen, serologic tests for syphilis, HCV antibody, or HIV antibody at prior examination
* Subjects who have experienced symptoms of alcohol abuse or excessive alcohol ingestion
* Subjects who test positive on urinalysis for drug use (amphetamine, benzodiazepine, barbiturates, cannabinoid, cocaine, opiates, and methadone) at prior examination
* Subjects who do not agree to use a physical contraceptive method during the study period
* Subjects who do not agree to use contraceptive methods for 90 days after final administration of the study drug
* Subjects who have consumed grapefruit, Seville orange, star fruit, cranberry, or any processed food containing these fruits within 7 days before the commencement of study drug administration
* Subjects who have consumed health foods containing St John's Wort within 2 weeks before study drug administration
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT01766167
Study Brief:
Protocol Section:
NCT01766167