Table 3.
Main baseline-corrected 25(OH)D3 plasma pharmacokinetic parameters after single-dose administration of Test and Reference preparations of vitamin D3
| Parameter | Vitamin D3 ODF | Vitamin D3 oral solution | |
|---|---|---|---|
| Fed (n = 16) | Fasting (n = 16) | Fed (n = 16) | |
| Cmax (ng/mL) | 6.68 ± 2.03 | 7.23 ± 1.48 | 6.61 ± 2.62 |
| AUC0−t (ng/mL × h) | 2364.80 ± 1336.97 | 2244.38 ± 1144.26 | 2150.52 ± 1622.76 |
| AUC0–∞ (ng/mL × h) | Calcifediol.21 ± 3903.59a | 3328.43 ± 1778.46b | 3582.27 ± 3144.33c |
| tmax (h) | 144 (36–312) | 42 (2–480) | 48 (12–312) |
| t½ (h) | 231.75 ± 199.59a | 236.76 ± 127.62b | 205.80 ± 142.39c |
| λz (1/h) | 0.01 ± 0.00a | 0 ± 0b | 0.01 ± 0c |
Values are arithmetic means ± standard deviation (SD), except for tmax, which are median (range)
AUC0−t area under the concentration-time curve (AUC) from time zero to last observed concentration-time, AUC0−∞t AUC extrapolated to infinity, CI confidence interval, Cmax maximum plasma concentration, ODF orally disintegrating film, PE point estimate, calculated as ratio of geometric means, tmax time to maximum plasma concentration, t½ half-life, λz terminal elimination rate constant
an = 9; bn = 11; cn = 10