A Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA of AZD0585 in Healthy Male Japanese Subjects

Phase 1 Completed 72 enrolled AstraZeneca

RandomizedCrossoverOpen-labelBasic science

Summary

The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male Japanese subjects.

Timeline

Start: 2015-03
Primary completion: 2015-05
Completion: 2015-05

Publications

Shimada H, Nilsson C, Noda Y, Kim H, Lundstrom T, Yajima T. Effects of Food on the Pharmacokinetics of Omega-3-Carboxylic Acids in Healthy Japanese Male Subjects: A Phase I, Randomized, Open-label, Three-period, Crossover Trial. J Atheroscler Thromb. 2017 Sep 1;24(9):980-987. doi: 10.5551/jat.38737. Epub 2017 Mar 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Epanova	Other / unclassified	4 g	Oral

Indications

No indication recorded.