Clinical Research Directory

Main Inclusion Criteria: * Body mass index: 18.0 to 30.0 kg/m2, inclusive * Good physical and mental health * Normal renal function (creatinine clearance ≥ 90 mL/min as determined by the Cockcroft-Gault equation) * Female participants of childbearing potential were required not be pregnant or lactating and had to agree to use adequate contraception * Male subjects, if not surgically sterilized, were required to agree to use adequate contraception * All prescribed medication had to be stopped at least 30 days prior to admission to the clinical research center (an exception was made for hormonal contraceptives) * All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (e.g., St. John's wort) had to be stopped at least 14 days prior to admission to the clinical research center * Ability and willingness to abstain from alcohol from 48 hours (2 days) prior to Screening and admission to the clinical research center * Ability and willingness to abstain from methylxanthine-containing beverages or food from 48 hours (2 days) prior to admission to the clinical research center Main Exclusion Criteria: * History of relevant drug and/or food allergies, particularly to antibiotics. * Subject received a known potent inhibitor of OATP1B activity within 30 days prior to admission * Subject received a potential inducer of OATP1B activity within 30 days prior to admission * Subject had a history of seizures * Subject had a history of frequent diarrhea * Smoking more than 5 cigarettes, 1 cigar, or 1 pipe daily; the use of tobacco products in the 48 hours (2 days) prior to admission * History of alcohol abuse or drug addiction within 12 months prior to Screening. * Average intake of more than 24 units of alcohol per week * Positive drug and/or alcohol screen * Donation or loss of more than 450 mL of blood within 60 days prior to the first pitavastatin administration on Day 1 of the current study. Donation or loss of more than 1.5 liters of blood (for male subjects)/more than 1.0 liters of blood (for female subjects) in the 10 months prior to the first pitavastatin administration on Day 1 of the current study.