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 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT04114461
Eligibility Criteria:
Inclusion Criteria:
* Years 19-60
* No pathological symptoms or findings
* Suitable for the criteria for examination
* 90≤SBP≤139, 60≤DBP≤89
* Body weight≥50kg (Female≥45kg) and 18≤BMI≤30kg/m2
* Contraceptive during the study period
* Volunteer for the study and sign to ICF
Exclusion Criteria:
* Subject with medical history which affect on the absorption of drug
* Following condition: Mental illness, Hepatic disorder, Tuberculosis, ANC\< 500cells/mm3, ALC\<500cells/mm3, Hb\<8g/dL
* Subject with hypersensitivity reaction to HL-TOF and Xeljanz
* Subject with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Subject who take a vaccination within 30 days
* Subject who take a medication such as barbiturates within 30 days
* Subject who take a medication that affect to the pharmacokinetics of drug within 10 days
* Subject who take alcohol more than 21 cups per week
* Subject who smoke 20 cigarettes per day
* Subject who participate in any clinical investigation within 6 month prior to study medication dosing
* Subject with whole blood donation within 60 days, component blood donation within 14 days, blood donation within 30 days
* Subject with decision of non-participation through investigator's review
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
60 Years
Study:
NCT04114461
Study Brief:
Protocol Section:
NCT04114461