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

NCT ID: NCT07201545

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-07

Study Completion Date

2025-12-10

Brief Summary

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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

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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

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Healthy Subjects

Keywords

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Healthy Subjects Bioequivalence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reference Formulation

Healthy participants who are randomized to receive co-administration of bempedoic acid 180 mg/ezetimibe 10 mg + rosuvastatin 20 mg (reference formulation).

Group Type ACTIVE_COMPARATOR

Bempedoic acid

Intervention Type DRUG

180 mg film coated tablet administered as FDC or co-administered with ezetimibe

Component of FDC

Ezetimibe

Intervention Type DRUG

10 mg tablet administered as FDC or co-administered with bempedoic acid

Component of FDC

Rosuvastatin

Intervention Type DRUG

20 mg film coated tablet administered individually or as FDC

Component of FDC

Test Formulation

Healthy participants who are randomized to receive the fixed dose triplet combination with bempedoic acid 180 mg/ezetimibe 10 mg/rosuvastatin 20 mg (test formulation).

Group Type EXPERIMENTAL

Bempedoic acid

Intervention Type DRUG

180 mg film coated tablet administered as FDC or co-administered with ezetimibe

Component of FDC

Ezetimibe

Intervention Type DRUG

10 mg tablet administered as FDC or co-administered with bempedoic acid

Component of FDC

Rosuvastatin

Intervention Type DRUG

20 mg film coated tablet administered individually or as FDC

Component of FDC

Interventions

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Bempedoic acid

180 mg film coated tablet administered as FDC or co-administered with ezetimibe

Component of FDC

Intervention Type DRUG

Ezetimibe

10 mg tablet administered as FDC or co-administered with bempedoic acid

Component of FDC

Intervention Type DRUG

Rosuvastatin

20 mg film coated tablet administered individually or as FDC

Component of FDC

Intervention Type DRUG

Other Intervention Names

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Nilemdo® Ezetrol® Crestor®

Eligibility Criteria

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Inclusion Criteria

1. Healthy male and female participants ≥18 and ≤60 years, at the time of signing the informed consent.
2. Body mass index (BMI) ≥18.5 and ≤30.0 kg/m\^2.
3. Female participants of childbearing potential agree to undergo pregnancy tests, and if with a non-vasectomized nor infertile male partner, agree to use an appropriate method of contraception.
4. No clinically relevant diseases captured in medical history.
5. No clinically relevant abnormalities on physical examination.
6. No clinically relevant abnormalities on vital signs.
7. No clinically relevant abnormalities on 12-lead electrocardiogram (ECG).
8. No clinically relevant abnormalities on clinical laboratory tests.
9. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) above the upper limit of normal range (ULN).
10. Estimated renal creatinine clearance (CrCl) above the lower limit of normal range, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average body surface area of 1.73 m\^2.
11. Willingness to accept and comply with all study procedures and restrictions.
12. Non-smoker or ex-smoker (i.e., someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening).
13. Ability to comprehend and willingness to freely sign the informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BlueClinical Phase I BlueClinical - Investigação e Desenvolvimento em Saúde, Lda.

Porto, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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2024-519852-10-00

Identifier Type: OTHER

Identifier Source: secondary_id

DSE-BMP-0004-CIS-MA

Identifier Type: -

Identifier Source: org_study_id