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

Sponsor
Daiichi Sankyo
Study ID
NCT07201545
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Bempedoic acid — DRUG
    180 mg film coated tablet administered as FDC or co-administered with ezetimibe Component of FDC
  • Ezetimibe — DRUG
    10 mg tablet administered as FDC or co-administered with bempedoic acid Component of FDC
  • Rosuvastatin — DRUG
    20 mg film coated tablet administered individually or as FDC Component of FDC

Study Details

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.

Key Dates

Start date
Oct 7, 2025
Status verified
Dec 2025
Primary completion
Dec 10, 2025
Completion
Dec 10, 2025

Study Design

Enrollment
58 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: 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).
  • Active Comparator: Reference Formulation
    Healthy participants who are randomized to receive co-administration of bempedoic acid 180 mg/ezetimibe 10 mg + rosuvastatin 20 mg (reference formulation).

Primary Outcome Measure

Pharmacokinetic Parameter Area Under the Curve (AUC) [ Time Frame: 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 ]

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