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The Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects

NCT01486433 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2015-04-30

No results posted yet for this study

Summary

The primary objective is to determine the effect of multiple doses of Epanova® (omega fatty acids) on the pharmacokinetics (PK) of multiple 40 mg doses of simvastatin.

Conditions

  • Hypertriglyceridemia

Interventions

DRUG

Simvastatin

40 mg (1 tablet) simvastatin once a day

DRUG

acetylsalicylic acid (ASA)

81 mg aspirin (1 tablet), once a day, co-administered with simvastatin

DRUG

omefas

4 g (4 capsules) Epanova once a day, co-administered with simvastatin and aspirin

Sponsors & Collaborators

Principal Investigators

  • Michael H Davidson, MD, FACC · Omthera Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01486433 on ClinicalTrials.gov