4.4. Study Design
BLOOD
This study utilized a randomized, open-label, single-dose, crossover design to assess the PK of two different ω-3 acid ethyl ester formulations. The randomization process was conducted by a biostatistics expert, who assigned each participant a unique random number in chronological order of enrollment. This number determined the sequence order of treatment administration for each participant, either starting with the novel IMD-Omega and then moving on to OmacorImportantly, no participants were excluded from the study after randomization, ensuring the integrity of the randomized design. Each participant received a single dose of either the test drug (IMD-Omega) or the reference drug (OmacorBlood samples were collected at various time points. The first blood sample was obtained after the participants had fasted for −24, −20, −16, −12, and 0 h before intake of the supplements. Subsequent blood samples were collected at 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, and 72 h (To minimize the influence of meals on the pharmacokinetics of the supplements, participants were instructed to consume a standardized breakfast consisting of 600–750 kcal with a fat content of 15–20% within 20 min before medication administration.Additionally, various screening tests were conducted on the participants, including hematology, blood chemistry, urine, and serology tests. Specifically, blood chemistry tests for AST (GOT), ALT (GPT), and γ-GTP were performed. Post-administration blood chemistry tests were conducted 72 h after each drug administration to assess potential changes in liver function.Blood samples were processed via centrifugation, separating the plasma from white and red blood cells, and stored at −80 °C for further analysis. The study design is summarized in 