NCT01486433

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

An Open-Label, Randomized, 2-Way Crossover Study to Evaluate the Effect of Multiple Doses of Epanova® on the Multiple-Dose Pharmacokinetics of Simvastatin in Healthy Normal Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study is testing the hypothesis that there is no interaction between Epanova and concomitant administration of simvastatin and aspirin. No drug interaction will be claimed if, following concomitant administration of simvastatin, aspirin and Epanova or only simvastatin and aspirin, the 90% confidence intervals (CIs) for the geometric mean ratios (GMRs) of the back-transformed PK parameters, area under the plasma concentration versus time curve (AUC0-tau) and concentration at the end of a dosing interval (Cmax,ss), for simvastatin and beta- hydroxysimvastatin acid,fall within 80%-125%.

Conditions

• Hypertriglyceridemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-12-06
• Last updated: 2015-04-30

Locations

1 site across 1 country: United States