This is a randomized, single-center, open-label, three-period, six-sequence, crossover, comparative study to evaluate the oral bioavailability of single doses of three vapendavir drug product formulations (the 264 mg free base tablet \[test drug\], 264 mg free base oral suspension \[test drug\], and two 132 mg phosphate salt capsules \[reference drug\]) in healthy volunteers. The study design consists of six dosing sequences. Each sequence comprises 3 periods and each subject is administered one of the three dosing formulations in the first period. A subject receives a different formulation in each of the subsequent periods, so that all subjects receive each formulation. The periods are separated by an approximate 7-day washout.
Owner of Study Record: Vaxart Inc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
48
Aviragen Investigational Site
Saint Paul, Minnesota, United States
Relative oral bioavailability, as applicable
Time frame: Study Day 0 - 17
Maximum observed plasma concentration (Cmax)
Time frame: Study Day 0 - 17
Time at which Cmac was observed (Tmax)
Time frame: Study Day 0 - 17
Area under the plasma concentration time curve from time ) to the last measureable plasma concentration (AUC 0-last)
Time frame: Study Day 0 - 17
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