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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT03713892
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult Korean or Caucasian aged 19 to 45 (inclusive) years, at the time of screening.
* Subjects weighing ≥ 50 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.
* Subjects who agreed to voluntarily participate in this study and comply with all the protocol requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study.
* Subjects who were deemed as eligible subjects by investigators on their physical examination, laboratory findings, and medical examination by interview.
Exclusion Criteria:
* Subjects with a history of hypersensitivities to the drug, including investigational drugs or other drugs or with a history of clinically significant hypersensitivities.
* Subjects with a history of drug abuse or a positive urine screening for drug abuse.
* Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within three months prior to study drug administration.
* Subjects who have donated a unit of whole blood within 60 days or blood components within 30 days prior to study drug administration.
* Subjects judged ineligible for the study after a review of the clinical laboratory results by the investigator or for other reasons.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
45 Years
Study:
NCT03713892
Study Brief:
Protocol Section:
NCT03713892