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 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT01427868
Eligibility Criteria:
Inclusion Criteria:
* Male with good health
* 20 to 45 years of age at screening
* Body weight ±20% of ideal body weight
* Willingness and ability to comply with study procedures and communicate with investigators
* Provided written consent voluntarily after informed of all the pertinent aspects of the trial
Exclusion Criteria:
* Clinically significant abnormality on medical interview, physical examination, electrocardiogram or clinical laboratory evaluations
* Clinically significant acute or chronic medical conditions
* Use of prescriptive medicine within 14 days, or over-the-counter drug within 7 days before the first day of drug administration
* Participation in clinical trial within 3 months before the first day of drug administration
* Alcohol abuse
* Habitual smoker
* Habitual user of herbal medicine
* Use of grapefruit-containing food or grapefruit juice during the study period
* Positive drug abuse test and Positive HBs-antigen, HCV-antibody, or HIV-antibody test
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01427868
Study Brief:
Protocol Section:
NCT01427868