NCT07182383

Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual 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 lower low density lipoprotein cholesterol (LDL-C) and reduce atherosclerotic cardiovascular disease risk in patients unable to reach individualized serum LDL-C levels. This study will test the bioequivalence of a test fixed dose combination (FDC) vs the co-administration of individual tablets.

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 individually or as FDC Component of FDC
DRUG	Ezetimibe	10 mg tablet administered individually or as FDC Component of FDC
DRUG	Rosuvastatin	20 mg film coated tablet administered individually or as FDC Component of FDC

Timeline

• Start date: 2025-09-29
• Primary completion: 2025-11-24
• Completion: 2025-11-24
• First posted: 2025-09-19
• Last updated: 2025-12-16

Locations

1 site across 1 country: Portugal