drugset / Trial / NCT03438955

Phase I Drug-drug Interaction of Omega-3 and Atorvastatin

NCT03438955

Phase 1 Unknown 48 enrolled DongKoo Bio & Pharma
Non-randomizedParallel-groupOpen-labelOther

Summary

This study evaluates the safety and pharmacokinetic drug-drug interactions of omega-3 and atorvastatin in healthy male volunteers. Half of the participants will receive omega-3 for 16 days to be steady state of omega-3 and followed by omega-3 and atorvastatin in combination for 7 days. The other half will receive Atorvastatin for 7 days to be steady state of Atorvastatin, and followed by Atorvastatin and Omega-3 in combination for 16 days.

Timeline

Start
2018-02-01
Primary completion
2018-07-31
Completion
2018-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Lovaza Other / unclassified 4000 mg Oral
Subject Telmisartan Other / unclassified 40 mg Oral

Indications