Pharmacokinetic and Safety Comparison of 2 Afatinib Dimaleate Tablets in Healthy Chinese Volunteers Under Fasted Conditions: A Randomized, Open‐Label, 2‐Period, Single‐Dose Crossover Study
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DOI: 10.1002/cpdd.1134
Abstract: In this bioequivalence study, we aimed to evaluate the bioequivalence of test (T) and reference (R) afatinib dimaleate tablets in healthy Chinese subjects under fasted conditions. This was a randomized, open‐label, 2‐period, single‐dose, crossover study.… read more here.
Keywords: period; crossover; afatinib dimaleate; fasted conditions ... See more keywords
Evaluation of the effects of formulation, food, or a proton-pump inhibitor on the pharmacokinetics of glasdegib (PF-04449913) in healthy volunteers: a randomized phase I study
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DOI: 10.1007/s00280-018-3748-8
Abstract: PurposeTo demonstrate the bioequivalence of the planned maleate salt-based commercial glasdegib tablet formulation [International Council for Harmonization (ICH) glasdegib] to the clinical di-hydrochloride (di-HCl) salt-based glasdegib formulation (di-HCl glasdegib). Additionally, to estimate the effects of… read more here.
Keywords: glasdegib; pump inhibitor; formulation; fasted conditions ... See more keywords