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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT00480467
Eligibility Criteria:
Inclusion criteria:
* Men aged 20 to 45 years (inclusive) at the time of getting informed consent.
* Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight≥50 kg (BMI = \[weight (kg)\]/\[height (m)\]2).
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine levels must be within the upper limit of normal for eligibility.
Exclusion criteria
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results.
* Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing products is prohibited from 72 hours before study day 1.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT00480467
Study Brief:
Protocol Section:
NCT00480467