An Open-label, 2-cohort Study to Evaluate the Effect of Multiple Doses of Epanova on the Single Dose Pharmacokinetics and Pharmacodynamics of Warfarin and to Compare the Systemic Exposure of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Following Multiple-dose Administrations of Epanova Compared to Lovaza in Healthy Normal Subjects.

Trial Profile

An Open-label, 2-cohort Study to Evaluate the Effect of Multiple Doses of Epanova on the Single Dose Pharmacokinetics and Pharmacodynamics of Warfarin and to Compare the Systemic Exposure of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) Following Multiple-dose Administrations of Epanova Compared to Lovaza in Healthy Normal Subjects.

Completed
Phase of Trial: Phase I

Latest Information Update: 14 Feb 2017

At a glance

  • Drugs Omega-3 carboxylic acids (Primary) ; Omega-3-acid ethyl esters; Warfarin
  • Indications Atrial fibrillation; Cardiovascular disorders; Heart failure; Hypertriglyceridaemia; IgA nephropathy; Major depressive disorder; Postmyocardial infarction; Thromboembolism
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Omthera Pharmaceuticals
  • Most Recent Events

    • 14 Feb 2017 Results of this and another phase I trial (NCT01486433) published in the American Journal of Cardiovascular Drugs.
    • 06 Jan 2012 Actual patient number (52) added as reported by ClinicalTrials.gov.
    • 06 Jan 2012 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
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