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NCT05729386
A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fed Conditions
Conditions: Healthy Volunteers
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 34
Sponsor: GC Biopharma Corp
Location: Korea, Republic of
Summary
The purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of GC2129A in fed conditions to healthy adult volunteers.
Eligibility Criteria
Inclusion Criteria:A person who is 19 years of age or older at the time of a screening visitA 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 visitA 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 examinationExclusion 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 surgeryThose 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 dateA person who participates in another clinical trial or biological equivalence test within six months of the first administration dateA 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 weeksA 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 criteriaIn the case of female volunteers, a pregnant woman or pregnant woman is suspected
Source: ClinicalTrials.gov (NCT05729386). StuddyBuddy aggregates publicly available trial information.