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

Hypertriglyceridemia Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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%. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01486433
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 1
Start date November 2011
Completion date March 2012
View Details
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