NCT07268625

Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin

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

• 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

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.

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	Atorvastatin	40 mg tablet administered as FDC or individually (Component of FDC)

Timeline

• Start date: 2025-12-09
• Primary completion: 2026-02-24
• Completion: 2026-02-24
• First posted: 2025-12-08
• Last updated: 2026-02-27

Locations

1 site across 1 country: Portugal