Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Rosuvastatin
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
58actual
Sites
1
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 | 2025-09-29 | actual | When the study began enrolling |
| Primary completion | 2025-11-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-11-24 | actual | The whole study's end, after follow-up |
| First posted | 2025-09-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-16 | 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: Rosuvastatin — also filed as Crestor®
Primary outcomes
what the primary-completion date above is the date OFPharmacokinetic 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) post-dose
Pharmacokinetic Parameter Maximum Observed Concentration (Cmax)
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) post-dose
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