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 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT01341392
Eligibility Criteria:
Inclusion Criteria:
* Between 20 aged and 45 years old in healthy males
* Body weight ≥ 55kg and 18.5 ≤ IBW \< 25
* Agreement with written informed consent
Exclusion Criteria:
* Subject has a history affects the ADME of drug
* Hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party
* Inadequate subject by medical examination(medical history, physical examination, ECG, laboratory test)
* AST,ALT \> UNL \* 1.25 or Total bilirubin \> UNL \* 1.5
* Estimated GFR(MDRD) \< 80
* SBP \>150 mmHg, SBP \< 100 mmHg or DBP \> 100 mmHg, DBP \< 60 mmHg or Pulse \> 100 per/min, Pulse \< 50 per/min
* Substance abuse, or a history of drug abuse showed a positive for the party
* Continued to be taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 210 g/week) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials
* Medication with drug-mediated induction/inhibition metabolic enzyme within 30 days or with may affect the clinical trial
* Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking
* Subject takes grapefruit within 1 month
* Previously participated in other trial within 60 days
* Previously donate whole blood within 60 days or component blood within 30 days
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT01341392
Study Brief:
Protocol Section:
NCT01341392