4.2. Inclusion and Exclusion Criteria of the Participants
lipidemia, congenital or chronic diseases, psychiatric, allergies, allergic reactions
LIPIDEMIA, ALLERGIC REACTION, KIDNEY DISEASES, ALLERGIES, BLOOD, HYPOTHYROIDISM
This study was carried out at the clinical research center of Bumin Hospital in Seoul, Republic of Korea. We recruited 50 healthy male volunteers aged 19 and above. Each participant underwent a thorough medical history review, a physical examination, and a blood test before being included in the study. To be eligible, participants needed to have a body mass index (BMI) within the range of 18 to 30 kg/mInclusion criteria required that participants did not have any significant congenital or chronic diseases requiring treatment within the past 5 years, and they should not have exhibited any pathological symptoms during the examination. Participants were also advised to avoid participating in any other clinical research utilizing investigational medications for at least 30 days prior to enrolling in this study.Several exclusion criteria were set in place to ensure the integrity and reliability of the study conclusions. Individuals were excluded if they had recently consumed drug-metabolizing enzymes, such as barbiturates, within 30 days before the first administration of investigational drugs. Those with a history of fish oil allergies or allergic reactions to lipids were also excluded from the study. Furthermore, anyone taking medications that could potentially interfere with the study had to refrain from participation within 10 days before receiving the investigational drug. Participants who had been part of another clinical trial within 6 months prior to the first administration of the investigational drug were also ineligible. Blood donation within 2 months or component blood donation within 2 weeks before the first administration of the investigational product were additional exclusion criteria.Individuals with certain medical conditions were not allowed to participate, including those with neurological, psychiatric, cardiovascular, pulmonary, endocrine, hematological, or immunological problems. Participants with GI tract, liver, or kidney diseases that might affect drug absorption, as well as individuals with excessive alcohol consumption (males > 14 drinks/week) within 1 month before the study, were also excluded. Smokers were not eligible to participate in the trial. Individuals with hypothyroidism, moderate-to-severe lipidemia (total cholesterol ≤ 240 mg/dL, LDL ≤ 160 mg/dL, and TG ≤ 199 mg/dL), systolic blood pressure over 160 mmHg, diastolic blood pressure higher than 95 mmHg, or resting cardiac output less than 40 beats/min or over one hundred beats/min were excluded from the study.Eligibility for participation was determined by the study investigator based on each participant’s medical history and the results of the screening tests. Before agreeing to participate, all subjects received a comprehensive explanation of the study’s purpose, design, and procedures (