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A Randomized, Single-Center, Open-Label, Single-dose, 4-Period, 2-Sequence, Fully Replicate Crossover Study To Assess The Bioequivalence Of A Test Fixed Dose Combination Product Versus The Co-Administered Individual Reference Products Containing Bempedoic Acid 180 mg, Ezetimibe 10 mg And Rosuvastatin 20 mg In Healthy Participants

Trial Profile

A Randomized, Single-Center, Open-Label, Single-dose, 4-Period, 2-Sequence, Fully Replicate Crossover Study To Assess The Bioequivalence Of A Test Fixed Dose Combination Product Versus The Co-Administered Individual Reference Products Containing Bempedoic Acid 180 mg, Ezetimibe 10 mg And Rosuvastatin 20 mg In Healthy Participants

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 21 Nov 2025

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At a glance

  • Drugs Bempedoic acid/ezetimibe/rosuvastatin (Primary) ; Bempedoic acid; Ezetimibe; Rosuvastatin
  • Indications Dyslipidaemias
  • Focus Pharmacokinetics
  • Sponsors Daiichi Sankyo Company

Most Recent Events

  • 18 Nov 2025 Status changed from not yet recruiting to recruiting.
  • 29 Sep 2025 Planned End Date changed from 25 Nov 2025 to 18 Nov 2025.
  • 29 Sep 2025 Planned primary completion date changed from 25 Nov 2025 to 18 Nov 2025.

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