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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT02819934
Eligibility Criteria:
Inclusion Criteria:
* Are able to provide written informed consent
* The subject is a healthy Korean aged 20 to 55 years, inclusive.
* The subject weighs at least 55 and has a body mass index (BMI)over 27
Exclusion Criteria:
* Subjects with evidence or a history of clinically significant pulmonary, cardiovascular, hepatic, endocrine, hematological, neurologic or psychiatric diseases.
* Subjects with evidence of gastrointestinal disease which can affect the absorption of drug.
* Subjects with a history of drug abuse or a positive result in the urine drug screening for drug abuse
* Subjects who have taken any prescribed medicine or herbal medicine within 2 weeks before the first administration of the investigational product, any non-prescribed medicine or vitamin supplement within 1 week prior the first administration of the investigational product (if all other conditions are satisfied, subjects may be eligible for the trial as judged by the investigator.)
* Subjects who have donated a unit of whole blood within 30 days or who have participated in any other clinical trial within 60 days prior the first administration of the investigational product
* Subject who have history of allergy.
* Subject who can not continue proper contraception method during study period.
* Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the PK/PD testing period
* Subjects who are unable to abstain from smoking during the PK/PD testing period
* Subjects who are unable to abstain from grapefruit or caffeine containing food 1 day prior the first administration of the investigational product
* Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
55 Years
Study:
NCT02819934
Study Brief:
Protocol Section:
NCT02819934