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 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT02183259
Eligibility Criteria:
Inclusion Criteria:
* healthy male subjects
* age: \>= 20 and \<= 35 years
* weight: \>= 50 to \<= 80 kg and within +/- 20 % of standard weight
* blood pressure: systolic 100 - 138 mmHg and diastolic of less than 84 mmHg
* pulse rate: 45 to 80 beat/min
* volunteer whose participation in the trial is judged valid by the investigator based on the results of preliminary check-up and pre-administration check-up
Exclusion Criteria:
* history of diseases including cardiac, pulmonary, hepatic, renal or gastrointestinal disease
* history of drug allergy
* history of drug dependency, alcohol dependency, etc.
* use of other trial drug within 6 months before study drug administration
* use of any drugs within 7 days before study drug administration
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
35 Years
Study:
NCT02183259
Study Brief:
Protocol Section:
NCT02183259