This is a Phase 1, open-label, 2-cohort, food-effect, DDI, and formulation bridging study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
oral capsule/tablet, QD
oral solution, QD
Celerion
Lincoln, Nebraska, United States
Maximum observed concentration (Cmax) in Plasma
Time frame: Up to 8 days post-dose
Time to maximum observed concentration (tmax) in Plasma
Time frame: Up to 8 days post-dose
Area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-last) in Plasma
Time frame: Up to 8 days post-dose
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) in Plasma
Time frame: Up to 8 days post-dose
Apparent terminal elimination half-life (t1/2) in Plasma
Time frame: Up to 8 days post-dose
Apparent clearance (Cl/F) in Plasma
Time frame: Up to 8 days post-dose
Apparent volume of distribution (Vz/F) in Plasma
Time frame: Up to 8 days post-dose
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