A Relative Bioavailability, Bioequivalence, and Food Effect Study of Niraparib Tablets in Patients with Advanced Solid Tumors
Falchook G, Patnaik A, Richardson D, Harvey R, Sharma M, Hafez N, Hamilton E, Piha-Paul S, Barve M, Wise-Draper T, Patel M, Dowlati A, Pascuzzo J, Tang S, Faltermeier C, Malinowska I, Shtessel L, Striha A, Potocka E. A Relative Bioavailability, Bioequivalence, and Food Effect Study of Niraparib Tablets in Patients with Advanced Solid Tumors. Clinical Therapeutics 2024, 46: 228-238. PMID: 38423866, DOI: 10.1016/j.clinthera.2024.01.004.Peer-Reviewed Original ResearchHigh-fat mealFood effectPK parametersSolid tumorsGeometric least square meansAdvanced ovarian cancerAdvanced solid tumorsFood effect studyEstimate PK parametersSafety populationOpen-labelStandard therapyOvarian cancerPK variabilityFE stageMaintenance treatmentNiraparibDisease progressionSafety signalsTreatment periodInhibitor niraparibConcentration dataPatientsFasting stateCapsule formulation