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 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT03261427
Eligibility Criteria:
Inclusion Criteria:
* 19 years to 55 years healthy volunteers adult at screening visit
* For male, weight is more than 55 kg, for female, weight is more than 50 kg.
* Body mass index(BMI) value : 18.5 to 25.0 kg/m2
* If female, should be included one at least as following
* menopausal(menstruation for 2 years minimum)
* surgery infertility
Exclusion Criteria:
* Any history of drug overdose or dependence
* Female who is pregnant or nursing
* AST, ALT \> ULN\*1.25
* Total bilirubin \> ULN\*1.5
* CPK \> ULN\*1.5
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT03261427
Study Brief:
Protocol Section:
NCT03261427