Table V.
PK parameter | Statistics (n = 6) |
Formulation | ||||
---|---|---|---|---|---|---|
Solution | Crystalline tablet formulation without SDS | Crystalline tablet formulation with SDS | ASD capsule formulation 3f (API:PVP VA64) | ASD capsule formulation 7a (API:PVP K12) | ||
C max (nM) | Mean | 15,400 | 2630 | 4930 | 9240 | 6310 |
SD | 1340 | 1090 | 1990 | 2290 | 2490 | |
%CV | 8.68 | 41.4 | 40.4 | 24.8 | 39.5 | |
t max (h) | Median | 1.25 | 4 | 3.5 | 7 | 5.5 |
Range | 1–1.5 | 2–24 | 1.5–48 | 1.5–24 | 1.5–8 | |
AUC0–72 (nM h) | Mean | 377,000 | 86,400 | 171,000 | 303,000 | 222,000 |
SD | 50,300 | 32,700 | 88,000 | 111,000 | 95,600 | |
%CV | 13.3 | 37.8 | 51.4 | 36.7 | 43.0 | |
Rel BA (%) | Mean | NA | 22.7 | 44.3 | 80.6 | 57.6 |
SD | NA | 6.80 | 18.8 | 25.9 | 20.9 | |
%CV | NA | 30.0 | 42.5 | 32.1 | 36.3 |
NA not applicable, SD standard deviation, Cmax maximum concentration, Tmax time to achieve maximum concentration, AUC area under the curve, Rel BA relative bioavailability