A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fed Conditions
Healthy Volunteers
About this trial
This is an interventional treatment trial for Healthy Volunteers focused on measuring PK, GC2129A
Eligibility Criteria
Inclusion Criteria: A person who is 19 years of age or older at the time of a screening visit A person with a body mass index (BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less with a weight of 50 kg or more (45 kg or more for women) during a screening visit A person who has no clinically significant congenital or chronic disease during a screening visit and has no pathological symptoms or findings as a result of internal examination Exclusion Criteria: Persons with clinically significant diseases or history of the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and urinary reproductive system, mental and nervous system, musculoskeletal system, immune system, otolaryngology, skin system, and ophthalmology. A person who has a history of gastrointestinal surgery Those who have taken drug metabolism enzymes, such as barbiturate drugs, within one month of the first dose date or who have taken drugs that may interfere with this clinical trial within 10 days of the first dose date A person who participates in another clinical trial or biological equivalence test within six months of the first administration date A person who has donated whole blood within 8 weeks of the date of first administration, or has donated components within 2 weeks, or has received a blood transfusion within 4 weeks A person who is deemed unsuitable for participation in this clinical trial by the principle investigator(or the delegated sub-investigator) for reasons other than the above selection and exclusion criteria In the case of female volunteers, a pregnant woman or pregnant woman is suspected
Sites / Locations
- H Plus YangJi HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
GC2129A + Reference drugs
Reference drugs + GC2129A
Period 1: GC2129A, Period 2: Individual Components
Period 1: Individual Components, Period 2: GC2129A