Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2025-11-26

Target enrollment:

Participant gender:

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.

Phase:

PHASE1

Details

Lead Sponsor:

Daiichi Sankyo

Treatments:

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Ezetimibe
Rosuvastatin Calcium