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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT01094834
Eligibility Criteria:
Inclusion Criteria:
1. Healthy adult male subjects aged 20 to 45 years
2. The subject has a Body weight ≥50 kg and \<90 kg and Body Mass Index(BMI) ≥19.0 kg/m2 and \< 27.0 kg/m2.
3. A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
4. A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
Exclusion Criteria:
1\. A subject with sign or symptoms or previously diagnosed disease of respiratory, cardiovascular, endocrinology, liver, kidney, gastrointestinal, hematology, neurology and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse 2. A subject who had any allergic history to any drug (prescription drug or OTC medication etc.) 3. A subject who had received treatment with below listed drug within specified period prior to the first dose of study medication
* Within last 1 month : drug or food known CYP1A2 inducer or inhibitor
* Within 2 weeks : Prescribed or herbal or Non-prescribed medicine
* Within 3 days : Consumption of grapefruit juice/grapefruit containing products or orange juice/orange containing products, garlic extracted functional foods
* Within 3 days : Consumption of alcohol or caffeine 4. A subject who had participated in any other clinical study within the last 12 weeks 5. A subject from whom over 400mL of blood was sampled(whole blood or plasma donation, etc.) within last 12 weeks 6. A Subject with the known evidence of the following infections or drug abuse
* HIV, HBs, HCV
* cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine 7. Smoker or smoking cessation within 1 month or ex-smoker with positive results by cotinine test 8. AST or ALT greater than 1.5 times the upper limit of reference range or QTc \> 430 msec base on screening results 9. Blood pressure : SBP≥140mmHg, DBP≤85mmHg 10. A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01094834
Study Brief:
Protocol Section:
NCT01094834