Comparison of the pharmacokinetics of pitavastatin by formulation and ethnic group: an open-label, single-dose, two-way crossover pharmacokinetic study in healthy Caucasian and Japanese men.

Background And Objectives: Pitavastatin is a highly effective lipid-lowering drug (approved dose range 1-4 mg/day) with a distinctive metabolic pathway that has a low potential for drug interactions. The efficacy and safety of pitavastatin have been characterized in a broad clinical development programme conducted initially in Japanese patients. The objectives of the present study were to evaluate the pharmacokinetic bioequivalence of the European (EU) and Japanese (JP) formulations of pitavastatin 2 mg in healthy Japanese and Caucasian men, and to assess whether the bioavailability of each formulation was similar in the two ethnic groups.