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

NCT07201545 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-07
Primary Completion
2025-12-10
Completion
2025-12-10

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07201545 on ClinicalTrials.gov