NCT07201545

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

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 Rosuvastatin 20 mg in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Bempedoic acid	180 mg film coated tablet administered as FDC or co-administered with ezetimibe Component of FDC
DRUG	Ezetimibe	10 mg tablet administered as FDC or co-administered with bempedoic acid Component of FDC
DRUG	Rosuvastatin	20 mg film coated tablet administered individually or as FDC Component of FDC

Timeline

• Start date: 2025-10-07
• Primary completion: 2025-12-10
• Completion: 2025-12-10
• First posted: 2025-10-01
• Last updated: 2025-12-18

Locations

1 site across 1 country: Portugal