Bioequivalence Clinical Trial
Official title:
An Open-Label, Partial Crossover, Single-Dose Study to Evaluate the Pharmacokinetics, Dose-Proportionality, and Safety/Tolerability of Tablet Versus Capsule Formulations of KBP 5074 in Healthy Subjects
This is an open-label, partial crossover, single-dose study to evaluate the pharmacokinetics (PK), dose proportionality, and safety/tolerability of tablet versus capsule formulations of KBP-5074 in healthy subjects. The study is designed to evaluate the PK of a new tablet formulation versus that of the current capsule formulation. Data derived from this study, in addition to preclinical data and chemistry, manufacturing, and controls, will provide a basis for dose selection in future studies.
Twenty healthy subjects will be allocated 4:1 to either the crossover study groups (16 subjects) or to the 0.25 mg tablet single dose treatment (4 subjects). Subjects allocated to the crossover study groups will be randomized 1:1 to 0.5 mg tablet/capsule (8 subjects) or 1.0 mg tablet/capsule (8 subjects). Within the crossover study groups, subjects will be further randomized to receive a single dose of KBP-5074 (0.5 mg or 1.0 mg) in either capsule or tablet formulation in a 2-period crossover design with a 2-week washout period. The study duration for subjects in the crossover study groups will be approximately 7 weeks, which includes a 3-week screening period, and the 2 crossover single dose periods, which will be followed by a 2-week washout/follow-up period, respectively. Subjects allocated to the 0.25 mg dose cohort (n=4) will receive a single dose of 0.25 mg in tablet formulation only. The 0.25 mg tablet cohort will provide additional data for the evaluation of dose exposure for the tablet formulation. The study duration for the single dose arm will be 5 weeks, which includes a 3-week screening period, and the single dose which will be followed by a 2 week washout period. ;
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