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First received: September 23, 2025

Clinical Trial: Evaluating Bioequivalence of a Fixed Dose Combination Versus Tablets of Bempedoic Acid / Ezetimibe and Rosuvastatin

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Healthy Subjects

Study Type: INTERVENTIONAL


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-administ

Brief Summary: The recommended first-line treatment of cardiovascular disease is a statin monotherapy; however, combination therapies represent an opportunity for an individualized, patient centered approach to low density lipoprotein cholesterol (LDL-C) lowering and atherosclerotic cardiovascular disease risk reduction in patients unable to reach individualized serum LDL-C levels.This study will test the bioequivalence of a test fixed dose combination (FDC) product versus the co-administered individual reference products.

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