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Study to Evaluate the 2-Way Interaction Between Multiple Doses of Epanova™ and a Single Dose of Rosuvastatin (Crestor®)

NCT02859129 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2016-08-17

No results posted yet for this study

Summary

This study is intended to evaluate the potential 2-way reciprocal interaction between multiple doses of Epanova™ and a single dose of rosuvastatin

Conditions

  • Hypertriglyceridemia

Interventions

DRUG

rosuvastatin 40 mg tablet

Single oral dose of 40 mg (1 x 40 mg tablet) rosuvastatin (Crestor®) (Day 1).

DRUG

Epanova™ QD (2 x 1 g capsules)

Multiple oral doses of 2 g (2 x 1 g capsules) Epanova™ QD for 10 consecutive days (Days 4 to 13)

DRUG

Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose

Multiple oral doses of 4 g Epanova™ QD for 13 consecutive days with coadministration of single 40 mg oral dose of rosuvastatin (Crestor®) with the 11th dose of Epanova™ on Day 24

DRUG

Multiple (20) oral doses of 2 g Vascepa® every 12 hours

Multiple oral doses of 2 g (2 x 1 g capsules) Vascepa® every 12 hours for 20 consecutive days (Days 1 to 20).

Sponsors & Collaborators

Principal Investigators

  • Michael D Davidson, MD · Omthera Pharmaceuticals/AstraZeneca

  • Sandra M Connolly, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT02859129 on ClinicalTrials.gov