Open-Label Crossover Oral Bioequivalence Pharmacokinetics Comparison for a 3-Day Loading Dose Regimen and 15-Day Steady-State Administration of SUBA-Itraconazole and Conventional Itraconazole Capsules in Healthy Adults
George R. Thompson, Phoebe Lewis, Stuart Mudge, Thomas F. Patterson, Bruce Burnett
Abstract
levels of >1,000 ng/ml when they were administered S-ITZ (81%) than when they were administered C-ITZ (44%). The study drugs were well tolerated in both studies, with similar adverse events (AEs). All treatment-emergent AEs resolved after study completion. One volunteer receiving C-ITZ discontinued due to a treatment-unrelated AE in the steady-state administration study. No serious AEs were reported. Total, trough, and peak ITZ and OH-ITZ exposures were similar between the two formulations. Therefore, SUBA-ITZ, which has 35% less drug than C-ITZ, was bioequivalent to C-ITZ in healthy adult volunteers and exhibited a safety profile similar to that of C-ITZ.
Topics & Concepts
PharmacokineticsItraconazoleCrossover studyBioequivalenceBioavailabilityPharmacologyMedicineOral administrationRegimenInternal medicineAntifungalPlaceboDermatologyPathologyAlternative medicineAntifungal resistance and susceptibilityPharmaceutical studies and practicesCystic Fibrosis Research Advances