Juyoung Khwarg, Soyoung Lee, In-Jin Jang, Won-Ho Kang, Hye Jung Lee, Kyu Yeon Kim, Ki-Sun Jeong, Chongho Won, Youn Woong Choi, Dae Chul Ha, RaeHoon Jung, Min-Gu Han, Won Tae Jung, Kyu-Yeol Nam, YeSeul Kim, Kyung-Sang Yu, Jaeseong Oh
PURPOSE: Statins are widely used in combination with omega-3 fatty acids for the treatment of patients with dyslipidemia. The aim of this study was to compare the pharmacokinetic (PK) profiles of atorvastatin and omega-3-acid ethyl esters between fixed-dose combination (FDC) and loose combination in healthy subjects. METHODS: A randomized, open-label, single-dose, 2-sequence, 2-treatment, 4-period replicated crossover study was performed. Subjects were randomly assigned to one of the 2 sequences and alternately received four FDC soft capsules of atorvastatin/omega-3-acid ethyl esters (10/1000 mg) or a loose combination of atorvastatin tablets (10 mg × 4) and omega-3-acid ethyl ester soft capsules (1000 mg× 4) for four periods, each period accompanied by a high-fat meal...
2024: Drug Design, Development and Therapy