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

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NCT07235189

Sponsored by Daiichi Sankyo (industry) · 4568.T — their whole pipeline →.

Phase

Phase 1

Status

Completed

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

58actual

Sites

Country

Portugal

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2025-10-28

actual

When the study began enrolling

Primary completion

2026-01-28

actual

The date the last participant is measured for the primary outcome — the readout window

Study completion

2026-01-28

actual

The whole study's end, after follow-up

First posted

2025-11-19

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-02-02

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Healthy Subjects

Interventions

Drug: Bempedoic acid — also filed as Nilemdo®
Drug: Ezetimibe — also filed as Ezetrol®
Drug: Atorvastatin — also filed as Sortis®

Primary outcomes

what the primary-completion date above is the date OF

Pharmacokinetic Parameter Area Under the Curve (AUC)

measured Pre-dose (t=0h), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose

Maximum Observed Concentration (Cmax)

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