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

PHASE1CompletedINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

November 30, 2013

Study Completion Date

November 30, 2013

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).

Trial Locations (1)

07753

Celerion, Neptune City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY