None listed
Conditions
Interventions
Dietary Supplement : To evaluate the bioavailability of omega-3 fatty acids in different formulations, this study aims to compare and assess the safety and pharmacokinetic characteristics following ad
Sponsors
Metro Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy adults aged 19 to 70 years, inclusive, as of the screening visit date. 2) Individuals who have received a full explanation of the study, have fully understood its contents, and voluntarily agreed to participate by providing written informed consent, and who agree to comply with all study requirements and precautions.
Exclusion criteria
Exclusion criteria: 1) Individuals with a history of clinically significant hypersensitivity or allergic reactions to any components contained in the investigational product. 2) Individuals with acute or chronic severe diseases requiring treatment, including but not limited to: Cardiovascular diseases (e.g., congestive heart failure, coronary artery disease, myocardial infarction), Endocrine disorders (e.g., uncontrolled hyperlipidemia, thyroid disorders), Immune system diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, immunodeficiency disorders), Respiratory diseases (e.g., asthma), Hepatobiliary diseases, Renal and genitourinary diseases, Neurological disorders (central or peripheral), Psychiatric disorders, Musculoskeletal disorders, Inflammatory, hematologic, or oncologic diseases, Gastrointestinal diseases. 3) Individuals who have taken omega-3 supplements within 90 days prior to the first intake of the investigational product. 4) Individuals who have participated in another human study or clinical trial within 90 days prior to the first intake of the investigational product and received investigational products or drugs (administration via injection, ingestion, implantation, etc.); Participation in purely observational studies without administration of any drug or product is excluded from this criterion. 5) Individuals with a history or suspicion of alcohol dependence or drug abuse. 6) Current smokers who have smoked 10 or more cigarettes per day within 30 days prior to the screening visit. 7) Pregnant or breastfeeding women, or women who do not agree to use appropriate contraception* during the study period. Appropriate contraception includes hormonal contraceptives, intrauterine devices (IUDs) or intrauterine systems (IUS), double-barrier methods (use of a male condom together with a diaphragm or cervical cap with spermicide), or documented surgical sterilization. 8) Individuals deemed inappropriate for participation by the principal investigator based on clinical laboratory test results or other relevant reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentrations of omega-3 fatty acids (EPA and DHA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital sign;Physical Examination;Electrocardiogram (ECG);Clinical laboratory examination;Adverse Event | — |
Countries
Korea, Republic of
Contacts
Public ContactSung Dae Kwon
Metro Hospital
Outcome results
None listed