This study is to assess the bioequivalence of a test formulation of vadadustat (A) compared to a reference formulation of vadadustat (B)
This is a randomized, open-label, single-dose, two-period crossover study in healthy adults to assess the bioequivalence of a test formulation of vadadustat compared to the reference formulation of vadadustat. Blood samples for vadadustat PK will be collected at pre-dose (0 hour) and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 18, 24, 32, 40, and 48 hours post-dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
oral tablet
oral tablet
Research Site
Baltimore, Maryland, United States
Area under plasma concentration-time curve from 0 to last quantifiable concentration (AUClast)
Time frame: Baseline visit, 48 hours
Area under plasma concentration-time curve from 0 to infinity (AUCinf)
Time frame: Baseline visit, 48 hours
Area under plasma concentration-time curve from 0 to last sampling point (AUCall)
Time frame: Baseline visit, 48 hours
Observed maximum concentration (Cmax)
Time frame: Baseline visit, 48 hours
Time to reach Cmax
Time frame: Baseline visit, 48 hours
Time to reach Tmax
Time frame: Baseline visit, 48 hours
Mean residence time (MRT)
Time frame: Baseline visit, 48 hours
Elimination rate constant (Kel)
Time frame: Baseline visit, 48 hours
Apparent total body clearance (CL/F)
Time frame: Baseline visit, 48 hours
Apparent volume of distribution (Vd/F)
Time frame: Baseline visit, 48 hours
Terminal half-life (t1/2)
Time frame: Baseline visit, 48 hours
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