Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin
brief summary
Monotherapies for lowering LDL-C often do not achieve target lipid levels because they act on a single pathway, which may be insufficient in patients with high cardiovascular risk or complex lipid profiles. Triple combination therapies, targeting multiple mechanisms of cholesterol metabolism simultaneously, have demonstrated superior LDL-C reduction and better achievement of guideline recommended LDL-C goals. Additionally, combining treatments into a single regimen can improve patient adherence and compliance, further enhancing clinical outcomes. This study will test the bioequivalence of a test fixed dose combination (FDC) product versus the co-administered individual reference products.
official title
A Randomized, Single-center, Open-label, Single-dose, 4-period, 2-sequence, Fully Replicate Crossover Study To Assess The Bioequivalence of A Test Fixed Dose Combination Product Versus The Co-administered Individual Reference Products Containing Bempedoic Acid 180 mg / Ezetimibe 10 mg And Atorvastatin 40 mg In Healthy Participants