TABLE 3

Anidulafungin studies and design included for analysis

StudyDesign and objectivePhaseAnidulafungin doseNo. of subjectsPopulationNo. of samplesPK sampling times (h)
ADOPTSingle-dose, open-label study evaluating PKIV100 mg i.v. over 90 min8Healthy Caucasian obese males and females880.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48
VER002-1Multiple-dose, open-label study evaluating PKI100 mg i.v. over 90 min5Healthy Caucasian normal-wt males and females55Predose,1.75, 2, 2.25, 2.5, 3.5, 5.5, 7.5, 9.5, 13.5, 23.75
XBAESingle-dose, open-label study evaluating PKI100 mg i.v. over 90 min7Healthy Caucasian normal-wt males140Predose, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168